Stability by jizhen1947

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									NCIt Subset   NCIt Subset Preferred Term                       NCIt Concept
Code                                                           Code

C96074        Stability Product Form Terminology               C42887
C96074        Stability Product Form Terminology               C42888
C96074        Stability Product Form Terminology               C42889
C96083        Stability Study Pause Description Terminology    C96154
C96081        Stability Container Type Terminology             C43165
C96071        Stability Study Data File Reason Terminology     C96089
C96081        Stability Container Type Terminology             C43166
C96081        Stability Container Type Terminology             C43177
C96081        Stability Container Type Terminology             C43207
C96071        Stability Study Data File Reason Terminology     C96094
C96074        Stability Product Form Terminology               C60897
C96074        Stability Product Form Terminology               C60957
C96074        Stability Product Form Terminology               C60984
C96081        Stability Container Type Terminology             C43167
C96074        Stability Product Form Terminology               C42890
C96076        Stability Study Test Terminology                 C96100
C96071        Stability Study Data File Reason Terminology     C71778
C96081        Stability Container Type Terminology             C43168
C96074        Stability Product Form Terminology               C42891
C96081        Stability Container Type Terminology             C43169
C96081        Stability Container Type Terminology             C43178
C96081        Stability Container Type Terminology             C43180
C96081        Stability Container Type Terminology             C43181
C96081        Stability Container Type Terminology             C92708
C96074        Stability Product Form Terminology               C25158
C96081        Stability Container Type Terminology             C43182
C96081        Stability Container Type Terminology             C43183
C96081        Stability Container Type Terminology             C43185
C96074        Stability Product Form Terminology               C45414
C96076        Stability Study Test Terminology                 C96099
C96074        Stability Product Form Terminology               C42892
C96074        Stability Product Form Terminology               C42893
C96074        Stability Product Form Terminology               C42894
C96080        Stability Container Closure System Terminology   C96113
C96080        Stability Container Closure System Terminology   C96114
C96074        Stability Product Form Terminology               C42678
C96079        Stability Study Type Terminology                 C96111
C96074        Stability Product Form Terminology               C60884
C96074        Stability Product Form Terminology               C42895
C96074        Stability Product Form Terminology               C42896
C96074        Stability Product Form Terminology               C42897
C96077        Stability Study Method Type Terminology          C96164
C96081        Stability Container Type Terminology             C43198
C96079        Stability Study Type Terminology                 C96109
C96077   Stability Study Method Type Terminology          C96102
C96074   Stability Product Form Terminology               C60891
C96074   Stability Product Form Terminology               C42899
C96074   Stability Product Form Terminology               C42898
C96074   Stability Product Form Terminology               C42900
C96081   Stability Container Type Terminology             C43186
C96080   Stability Container Closure System Terminology   C96115
C96080   Stability Container Closure System Terminology   C96116
C96074   Stability Product Form Terminology               C28944
C96080   Stability Container Closure System Terminology   C96125
C96074   Stability Product Form Terminology               C42901
C96081   Stability Container Type Terminology             C43187
C96070   Stability Study Data File Type Terminology       C96086
C96074   Stability Product Form Terminology               C42902
C96074   Stability Product Form Terminology               C42903
C96074   Stability Product Form Terminology               C87540
C96074   Stability Product Form Terminology               C42997
C96074   Stability Product Form Terminology               C42904
C96074   Stability Product Form Terminology               C42905
C96083   Stability Study Pause Description Terminology    C96151
C96074   Stability Product Form Terminology               C45413
C96074   Stability Product Form Terminology               C42906
C96074   Stability Product Form Terminology               C42907
C96074   Stability Product Form Terminology               C42908
C96079   Stability Study Type Terminology                 C96110
C96081   Stability Container Type Terminology             C43190
C96081   Stability Container Type Terminology             C43191
C96074   Stability Product Form Terminology               C43525
C96081   Stability Container Type Terminology             C43170
C96081   Stability Container Type Terminology             C43208
C96074   Stability Product Form Terminology               C60927
C96074   Stability Product Form Terminology               C60928
C96074   Stability Product Form Terminology               C48624
C96081   Stability Container Type Terminology             C43192
C96074   Stability Product Form Terminology               C42679
C96074   Stability Product Form Terminology               C42763
C96074   Stability Product Form Terminology               C60992
C96074   Stability Product Form Terminology               C60995
C96081   Stability Container Type Terminology             C43171
C96074   Stability Product Form Terminology               C17423
C96081   Stability Container Type Terminology             C43197
C96081   Stability Container Type Terminology             C43233
C96074   Stability Product Form Terminology               C42909
C96074   Stability Product Form Terminology               C64884
C96074   Stability Product Form Terminology               C42910
C96074   Stability Product Form Terminology               C42911
C96074   Stability Product Form Terminology               C42912
C96074   Stability Product Form Terminology               C42913
C96074   Stability Product Form Terminology               C42914
C96074   Stability Product Form Terminology               C42915
C96074   Stability Product Form Terminology               C43451
C96074   Stability Product Form Terminology               C42916
C96074   Stability Product Form Terminology               C42917
C96074   Stability Product Form Terminology               C42918
C96074   Stability Product Form Terminology               C42919
C96074   Stability Product Form Terminology               C60929
C96074   Stability Product Form Terminology               C60926
C96074   Stability Product Form Terminology               C42928
C96074   Stability Product Form Terminology               C42920
C96074   Stability Product Form Terminology               C42935
C96074   Stability Product Form Terminology               C69067
C96074   Stability Product Form Terminology               C42921
C96074   Stability Product Form Terminology               C42922
C96074   Stability Product Form Terminology               C87538
C96074   Stability Product Form Terminology               C60934
C96074   Stability Product Form Terminology               C42923
C96074   Stability Product Form Terminology               C42924
C96074   Stability Product Form Terminology               C42925
C96074   Stability Product Form Terminology               C42927
C96074   Stability Product Form Terminology               C42929
C96078   Stability Study Interpretation Terminology       C44281
C96074   Stability Product Form Terminology               C42930
C96074   Stability Product Form Terminology               C42931
C96074   Stability Product Form Terminology               C42932
C96081   Stability Container Type Terminology             C96144
C96081   Stability Container Type Terminology             C79135
C96080   Stability Container Closure System Terminology   C96128
C96083   Stability Study Pause Description Terminology    C96153
C96081   Stability Container Type Terminology             C43189
C96074   Stability Product Form Terminology               C42933
C96074   Stability Product Form Terminology               C42934
C96074   Stability Product Form Terminology               C60994
C96074   Stability Product Form Terminology               C42936
C96074   Stability Product Form Terminology               C48193
C96081   Stability Container Type Terminology             C43172
C96081   Stability Container Type Terminology             C43203
C96081   Stability Container Type Terminology             C43209
C96074   Stability Product Form Terminology               C42937
C96074   Stability Product Form Terminology               C45416
C96074   Stability Product Form Terminology               C42938
C96074   Stability Product Form Terminology               C42939
C96074   Stability Product Form Terminology               C42940
C96078   Stability Study Interpretation Terminology       C61584
C96078   Stability Study Interpretation Terminology       C61583
C96074   Stability Product Form Terminology               C42941
C96080   Stability Container Closure System Terminology   C96129
C96071   Stability Study Data File Reason Terminology     C80440
C96082   Stability Study Storage Condition Terminology    C96146
C96083   Stability Study Pause Description Terminology    C96150
C96074   Stability Product Form Terminology               C42942
C96074   Stability Product Form Terminology               C42943
C96074   Stability Product Form Terminology               C42944
C96081   Stability Container Type Terminology             C16738
C96081   Stability Container Type Terminology             C43194
C96074   Stability Product Form Terminology               C42946
C96074   Stability Product Form Terminology               C42926
C96074   Stability Product Form Terminology               C42950
C96074   Stability Product Form Terminology               C42951
C96074   Stability Product Form Terminology               C42945
C96074   Stability Product Form Terminology               C42988
C96074   Stability Product Form Terminology               C42995
C96074   Stability Product Form Terminology               C60933
C96074   Stability Product Form Terminology               C47915
C96071   Stability Study Data File Reason Terminology     C82667
C96071   Stability Study Data File Reason Terminology     C96091
C96071   Stability Study Data File Reason Terminology     C96090
C96074   Stability Product Form Terminology               C42947
C96081   Stability Container Type Terminology             C43195
C96074   Stability Product Form Terminology               C42948
C96081   Stability Container Type Terminology             C43196
C96074   Stability Product Form Terminology               C47916
C96078   Stability Study Interpretation Terminology       C61585
C96078   Stability Study Interpretation Terminology       C61586
C96081   Stability Container Type Terminology             C96143
C96080   Stability Container Closure System Terminology   C96130
C96074   Stability Product Form Terminology               C42949
C96074   Stability Product Form Terminology               C60931
C96074   Stability Product Form Terminology               C42952
C96074   Stability Product Form Terminology               C42953
C96074   Stability Product Form Terminology               C42954
C96074   Stability Product Form Terminology               C29167
C96074   Stability Product Form Terminology               C60958
C96074   Stability Product Form Terminology               C42955
C96080   Stability Container Closure System Terminology   C96126
C96074   Stability Product Form Terminology               C87541
C96074   Stability Product Form Terminology               C42956
C96074   Stability Product Form Terminology               C42959
C96074   Stability Product Form Terminology               C42957
C96074   Stability Product Form Terminology               C42958
C96074   Stability Product Form Terminology               C42960
C96074   Stability Product Form Terminology               C60930
C96074   Stability Product Form Terminology             C42961
C96074   Stability Product Form Terminology             C42962
C96081   Stability Container Type Terminology           C96142
C96074   Stability Product Form Terminology             C29269
C96081   Stability Container Type Terminology           C43210
C96074   Stability Product Form Terminology             C42963
C96074   Stability Product Form Terminology             C42964
C96071   Stability Study Data File Reason Terminology   C96092
C96071   Stability Study Data File Reason Terminology   C72901
C96071   Stability Study Data File Reason Terminology   C72899
C96078   Stability Study Interpretation Terminology     C48660
C96074   Stability Product Form Terminology             C42965
C96074   Stability Product Form Terminology             C42966
C96074   Stability Product Form Terminology             C61006
C96074   Stability Product Form Terminology             C42999
C96081   Stability Container Type Terminology           C48626
C96081   Stability Container Type Terminology           C43184
C96081   Stability Container Type Terminology           C43193
C96081   Stability Container Type Terminology           C43206
C96081   Stability Container Type Terminology           C42794
C96081   Stability Container Type Terminology           C43199
C96074   Stability Product Form Terminology             C47887
C96081   Stability Container Type Terminology           C79136
C96081   Stability Container Type Terminology           C43226
C96078   Stability Study Interpretation Terminology     C81275
C96074   Stability Product Form Terminology             C42967
C96074   Stability Product Form Terminology             C60985
C96081   Stability Container Type Terminology           C82332
C96074   Stability Product Form Terminology             C42968
C96081   Stability Container Type Terminology           C43211
C96074   Stability Product Form Terminology             C42969
C96074   Stability Product Form Terminology             C87542
C96081   Stability Container Type Terminology           C96141
C96081   Stability Container Type Terminology           C43212
C96070   Stability Study Data File Type Terminology     C96087
C96076   Stability Study Test Terminology               C96098
C96081   Stability Container Type Terminology           C43213
C96074   Stability Product Form Terminology             C25394
C96074   Stability Product Form Terminology             C42970
C96081   Stability Container Type Terminology           C43173
C96081   Stability Container Type Terminology           C43204
C96081   Stability Container Type Terminology           C43214
C96081   Stability Container Type Terminology           C43200
C96074   Stability Product Form Terminology             C47913
C96074   Stability Product Form Terminology             C42971
C96074   Stability Product Form Terminology             C42972
C96074   Stability Product Form Terminology             C42977
C96074   Stability Product Form Terminology               C42974
C96074   Stability Product Form Terminology               C42976
C96074   Stability Product Form Terminology               C42973
C96074   Stability Product Form Terminology               C42975
C96071   Stability Study Data File Reason Terminology     C70880
C96071   Stability Study Data File Reason Terminology     C80442
C96080   Stability Container Closure System Terminology   C96123
C96080   Stability Container Closure System Terminology   C96124
C96077   Stability Study Method Type Terminology          C96103
C96082   Stability Study Storage Condition Terminology    C96148
C96081   Stability Container Type Terminology             C43174
C96080   Stability Container Closure System Terminology   C96131
C96080   Stability Container Closure System Terminology   C96132
C96083   Stability Study Pause Description Terminology    C96155
C96074   Stability Product Form Terminology               C42978
C96074   Stability Product Form Terminology               C60988
C96074   Stability Product Form Terminology               C42979
C96080   Stability Container Closure System Terminology   C96127
C96074   Stability Product Form Terminology               C42980
C96074   Stability Product Form Terminology               C42981
C96074   Stability Product Form Terminology               C42982
C96081   Stability Container Type Terminology             C43215
C96081   Stability Container Type Terminology             C43216
C96074   Stability Product Form Terminology               C87537
C96074   Stability Product Form Terminology               C87536
C96080   Stability Container Closure System Terminology   C96133
C96080   Stability Container Closure System Terminology   C96134
C96074   Stability Product Form Terminology               C42983
C96074   Stability Product Form Terminology               C42984
C96074   Stability Product Form Terminology               C42985
C96074   Stability Product Form Terminology               C42986
C96074   Stability Product Form Terminology               C42987
C96074   Stability Product Form Terminology               C47912
C96081   Stability Container Type Terminology             C43175
C96074   Stability Product Form Terminology               C42989
C96074   Stability Product Form Terminology               C42990
C96069   Stability Data Standards Terminology             C96080
C96069   Stability Data Standards Terminology             C96081
C96069   Stability Data Standards Terminology             C96074
C96069   Stability Data Standards Terminology             C96072
C96069   Stability Data Standards Terminology             C96071
C96069   Stability Data Standards Terminology             C96070
C96069   Stability Data Standards Terminology             C96078
C96069   Stability Data Standards Terminology             C96077
C96069   Stability Data Standards Terminology             C96083
C96069   Stability Data Standards Terminology             C96082
C96069   Stability Data Standards Terminology             C96076
C96069   Stability Data Standards Terminology             C96079
C96069   Stability Data Standards Terminology             C96075
C96070   Stability Study Data File Type Terminology       C96085
C96074   Stability Product Form Terminology               C42991
C96080   Stability Container Closure System Terminology   C96139
C96074   Stability Product Form Terminology               C47914
C96074   Stability Product Form Terminology               C42992
C96081   Stability Container Type Terminology             C43201
C96074   Stability Product Form Terminology               C42993
C96074   Stability Product Form Terminology               C42994
C96074   Stability Product Form Terminology               C47889
C96074   Stability Product Form Terminology               C47898
C96081   Stability Container Type Terminology             C43202
C96074   Stability Product Form Terminology               C42996
C96074   Stability Product Form Terminology               C60997
C96074   Stability Product Form Terminology               C42998
C96074   Stability Product Form Terminology               C61004
C96074   Stability Product Form Terminology               C61005
C96081   Stability Container Type Terminology             C43205
C96074   Stability Product Form Terminology               C87539
C96080   Stability Container Closure System Terminology   C96120
C96080   Stability Container Closure System Terminology   C96117
C96080   Stability Container Closure System Terminology   C96118
C96074   Stability Product Form Terminology               C47892
C96074   Stability Product Form Terminology               C47897
C96080   Stability Container Closure System Terminology   C96140
C96074   Stability Product Form Terminology               C43000
C96080   Stability Container Closure System Terminology   C96135
C96081   Stability Container Type Terminology             C53438
C96080   Stability Container Closure System Terminology   C96136
C96074   Stability Product Form Terminology               C43001
C96080   Stability Container Closure System Terminology   C96137
C96074   Stability Product Form Terminology               C43002
C96081   Stability Container Type Terminology             C43176
C96081   Stability Container Type Terminology             C43179
C96081   Stability Container Type Terminology             C43188
C96080   Stability Container Closure System Terminology   C96122
C96080   Stability Container Closure System Terminology   C96119
C96080   Stability Container Closure System Terminology   C96121
C96074   Stability Product Form Terminology               C47890
C96080   Stability Container Closure System Terminology   C96138
C96074   Stability Product Form Terminology               C43003
C96082   Stability Study Storage Condition Terminology    C96147
NCIt Preferred Term


Aerosol Dosage Form
Aerosol Foam Dosage Form
Aerosol Spray Dosage Form
Ambient Delayed Testing
Ampule
Annual Report
Applicator
Applicator Bottle
Applicator Tube
Approved Application Supplement
Augmented Cream Dosage Form
Augmented Lotion Dosage Form
Augmented Ointment Dosage Form
Bag
Bead Dosage Form
Biological or Textual Reference to Actual Test or Parameter
Biologics License Application
Blister Pack
Block Dosage Form
Bottle
Box
Can
Canister
Capsule
Capsule Dosage Form
Carton
Cartridge
Cello Pack
Cement Dosage Form
Chemical or Textual Reference to Actual Test or Parameter
Chewable Bar Dosage Form
Chewable Tablet Dosage Form
Chewing Gum Dosage Form
Child Resistant Metal Container Closure
Child Resistant Plastic Container Closure
Cigarette Dosage Form
Clinical Lot
Cloth Dosage Form
Coated Capsule Dosage Form
Coated Pellet in Capsule Dosage Form
Coated Tablet Dosage Form
Code of Federal Regulations Method
Combination Package
Commercial Lot
Compendial Method
Concentrated Dosage Form
Concentrated Injectable Solution Dosage Form
Concentrated Solution Dosage Form
Cone Dosage Form
Container
Continuous Thread Metal Container Closure
Continuous Thread Plastic Container Closure
Cream Dosage Form
Crown Metal Container Closure
Crystal Dosage Form
Cup
Cycled Drug Stability Study
Delayed Release Capsule Dosage Form
Delayed Release Granule Dosage Form
Delayed Release Granule for Suspension Dosage Form
Delayed Release Particle Tablet Dosage Form
Delayed Release Pellet in Capsule Dosage Form
Delayed Release Tablet Dosage Form
Delayed Testing
Dental Liner Dosage Form
Dentifrice Gel Dosage Form
Dentifrice Paste Dosage Form
Dentifrice Powder Dosage Form
Development Lot
Dewar
Dialpack
Disc Dosage Form
Dispensing Bottle
Dispensing Vial
Dosage Form for Solution
Dosage Form for Suspension
Dosage Form Not Applicable
Dose Pack
Douche Dosage Form
Dressing Dosage Form
Drop Solution Dosage Form
Drop Suspension Dosage Form
Dropper Bottle
Drug Delivery System
Drug Kit
Drug Package
Effervescent Granule Dosage Form
Effervescent Powder Dosage Form
Effervescent Tablet Dosage Form
Electrically Controlled Extended Release Patch Dosage Form
Elixir Dosage Form
Emulsion Dosage Form
Emulsion for Injection Dosage Form
Enema Dosage Form
Extended Release Bead Implant Dosage Form
Extended Release Capsule Dosage Form
Extended Release Coated Capsule Dosage Form
Extended Release Coated Pellet Dosage Form
Extended Release Core Dosage Form
Extended Release Dosage Form for Suspension
Extended Release Fiber Dosage Form
Extended Release Film Coated Capsule Dosage Form
Extended Release Film Dosage Form
Extended Release Gel Forming Solution Dosage Form
Extended Release Granule Dosage Form
Extended Release Granule for Suspension Dosage Form
Extended Release Insert Dosage Form
Extended Release Intraruminal Device Dosage Form
Extended Release Liquid Dosage Form
Extended Release Patch Dosage Form
Extended Release Suppository Dosage Form
Extended Release Suspension Dosage Form
Extended Release Tablet Dosage Form
Extract Dosage Form
Failed
Film Coated Extended Release Tablet Dosage Form
Film Coated Tablet Dosage Form
Film Dosage Form
Flask
Flexible Intermediate Bulk Container
Flip-Top Dispensing Plastic Container Closure
Frozen Delayed Testing
Gas Cylinder
Gas Dosage Form
Gel Dosage Form
Gel Forming Drop Solution Dosage Form
Gelatin Coated Capsule Dosage Form
Generator Dosage Form
Glass Bottle
Glass Syringe
Glass Vial
Globule Dosage Form
Graft Dosage Form
Granule Dosage Form
Granule for Solution Dosage Form
Granule for Suspension Dosage Form
Greater Than
Greater Than or Equal To
Gum Dosage Form
Hinged Dispensing Plastic Container Closure
Humanitarian Device Exemption
ICH Temperature/Humidity Storage Condition
Immediate Testing
Implant Dosage Form
Implantable Pellet Dosage Form
Inhalant Dosage Form
Inhaler
Inhaler Refill
Injectable Dosage Form
Injectable Extended Release Suspension Dosage Form
Injectable Lipid Complex Dosage Form
Injectable Liposomal Suspension Dosage Form
Injectable Solution Dosage Form
Injectable Sonicated Suspension Dosage Form
Injectable Suspension Dosage Form
Insert Dosage Form
Intrauterine Device Dosage Form
Investigational Device Exemption
Investigational New Animal Drug File
Investigational New Drug Application
Irrigant Dosage Form
Jar
Jelly Dosage Form
Jug
Kit Dosage Form
Less Than
Less Than or Equal To
Lined Canister
Linerless Plastic Container Closure
Liniment Dosage Form
Liposomal Injection Dosage Form
Lipstick Dosage Form
Liquid Dosage Form
Liquid Filled Capsule Dosage Form
Lotion Dosage Form
Lotion Shampoo Dosage Form
Lozenge Dosage Form
Lug Metal Container Closure
Lyophilized Powder Dosage Form
Lyophilized Powder for Extended Release Injectable Suspension Dosage Form
Lyophilized Powder for Injectable Liposomal Suspension Dosage Form
Lyophilized Powder for Injectable Solution Dosage Form
Lyophilized Powder for Injectable Suspension Dosage Form
Metered Aerosol Dosage Form
Metered Gel Dosage Form
Metered Powder Dosage Form
Metered Spray Dosage Form
Microwell Plate
Mouthwash Dosage Form
Multi Dose Vial
Multilayered Extended Release Tablet Dosage Form
Multilayered Tablet Dosage Form
New Active Ingredient
New Animal Drug Application
New Drug Application
Not Applicable
Oil Dosage Form
Ointment Dosage Form
Orally Disintegrating Delayed Release Tablet Dosage Form
Orally Disintegrating Tablet Dosage Form
Package Type Not Stated
Packaging Case
Packaging Drum
Packaging Tank
Packaging Tube
Packet
Packing Dosage Form
Pail
Parenteral Vial
Pass
Paste Dosage Form
Pastille Dosage Form
Patch
Patch Dosage Form
Patent Delivery System Vial
Pellet Dosage Form
Pendant Dosage Form
Petri Dish
Pharmacy Bulk Vial
Photostability Drug Study
Physical or Textual Reference to Actual Test or Parameter
Piggyback Vial
Pill Dosage Form
Plaster Dosage Form
Plastic Bottle
Plastic Syringe
Plastic Vial
Pouch
Poultice Dosage Form
Powder Aerosol Dosage Form
Powder Dosage Form
Powder for Injectable Extended Release Suspension Dosage Form
Powder for Injectable Solution Dosage Form
Powder for Injectable Suspension Dosage Form
Powder for Solution Dosage Form
Powder for Suspension Dosage Form
Premarket Approval Application
Premarket Device Notification
Press-On / Twist-Off Metal Container Closure
Press-On Composite Container Closure
Proprietary Method
Proprietary Storage Condition
Pump Bottle
Pump Dispensing Plastic Container Closure
Push-Pull Dispensing Plastic Container Closure
Refrigerated Delayed Testing
Resin Gum Dosage Form
Ring Dosage Form
Rinse Dosage Form
Roll On Metal Container Closure
Salve Dosage Form
Shampoo Dosage Form
Shampoo Suspension Dosage Form
Single Dose Vial
Single Use Vial
Smoke Paper Dosage Form
Smoke Stick Dosage Form
Snap-On Cap Plastic Container Closure
Snip-Tip Dispensing Plastic Container Closure
Soap Dosage Form
Soluble Film Dosage Form
Soluble Tablet Dosage Form
Solution Dosage Form
Solution for Slush Dosage Form
Sponge Dosage Form
Spray Bottle
Spray Dosage Form
Spray Suspension Dosage Form
Stability Container Closure System Terminology
Stability Container Type Terminology
Stability Product Form Terminology
Stability Product Identifier Terminology
Stability Study Data File Reason Terminology
Stability Study Data File Type Terminology
Stability Study Interpretation Terminology
Stability Study Method Type Terminology
Stability Study Pause Description Terminology
Stability Study Storage Condition Terminology
Stability Study Test Terminology
Stability Study Type Terminology
Stability Substance Identifier Terminology
Standard Drug Stability Study
Stick Dosage Form
Stopper Container Closure
Strip Dosage Form
Sugar Coated Tablet Dosage Form
Supersack
Suppository Dosage Form
Suspension Dosage Form
Suture Dosage Form
Swab Dosage Form
Syringe
Syrup Dosage Form
Tablet Coated Particle Dosage Form
Tablet Dosage Form
Tablet for Solution Dosage Form
Tablet for Suspension Dosage Form
Tabminder
Tag Dosage Form
Tamper Evident Composite Container Closure
Tamper Evident Metal Container Closure
Tamper Evident Plastic Container Closure
Tampon Dosage Form
Tape Dosage Form
Tie Container Closure
Tincture Dosage Form
Toggle-Swing Dispensing Plastic Container Closure
Tray
Trigger Spray Dispensing Plastic Container Closure
Troche Dosage Form
Twist Open/Close Dispensing Plastic Container Closure
Unassigned Dosage Form
Unit Dose Bottle
Unit Dose Box
Unit Dose Cup
Vacuum Sealed Composite Container Closure
Vacuum Sealed Metal Container Closure
Vacuum Sealed Plastic Container Closure
Vaginal Diaphragm Dosage Form
Valved Dispensing Plastic Container Closure
Wafer Dosage Form
WHO Temperature/Humidity Storage Condition
NCIt Definition


Contents packaged under pressure that are released upon activation of an appropriate valve system.
A foam that is packaged under pressure and released upon activation of an appropriate valve system.
A spray that is packaged under pressure and released upon activation of an appropriate valve system.

A container capable of being hermetically sealed, intended to hold sterile materials.

A pre-filled non-injectable pipette, syringe or tube.
A bottle which includes a device for applying its contents.
A tube which is provided with a device (the applicator) for administering the dosage form. The applicator may be part of the t

A cream that is modified to enhance the release of active and/or inert ingredient(s).
A lotion that is modified to enhance the release of active and/or inert ingredient(s).
An ointment that is modified to enhance the release of active and/or inert ingredient(s).
A sac or pouch.
A solid in the shape of a small sphere.

A formal submission to FDA from any legal person or entity to obtain permission for manufacturing and marketing a biologica
A package that consists of molded plastic or laminate that has indentations (viewed as 'blisters' when flipped) into which a do
A solid or semi-solid in the shape of a square or rectangle.
A vessel with a narrow neck designed to accept a specific closure.
A square or rectangular vessel, usually made of cardboard or plastic.
A cylindrical vessel, usually made of metal.
A type of can for holding a drug product.
A drug packaging type usually in a cylindrical shape with rounded ends. Capsule shells may be made from gelatin, starch, or ce
A solid contained within either a hard or soft soluble shell, usually prepared from gelatin.
A cardboard box or container which is usually considered a secondary packaging component.
A container consisting of a cylinder with a septum at one end, and a seal at the other end, which is inserted into a device to fo
A plastic 'clamshell' [thin plastic pre-formed structure for a device].
A base composed of bonding agents intermingled with active and/or inert ingredient(s), which rapidly hardens into a firm ma

A bar designed to be chewed to release active and/or inert ingredient(s).
A tablet designed to be chewed to release the active and/or inert ingredient(s).
A semi-solid composed of synthetic, polymerized polysaccharide and flavorings, intended to be chewed to release active and


A solid composed of active and/or inert ingredient(s) wrapped in a paper cylinder whereby one end is burned. The ingredient

A solid composed active and/or inert ingredient(s) in a woven absorbent material.
A capsule that contains an additional outer layer over the capsule shell.
A capsule composed of small globular masses covered with an outer shell.
A tablet whose outer shell is covered with a substance.

A package in which two or more drug products that are normally available separately are now available together.
A solution or suspension composed of active and/or inert ingredient(s) with increased strength in a reduced volume, which is
A concentrate which is usually diluted prior to administration by injection.
A concentrate which is usually diluted prior to administration and exists as a solution in its final form.
A solid with a shape bounded by a circular base converging upon a single vertex.
An object that can be used to hold things.


A semi-solid composed of an emulsion of lipids, hydrocarbons, waxes, or polyols in water.

A solid that consists of naturally produced angular solids composed of singular, repeating units that are systematically arrang
A bowl-shaped container.

A capsule covered with a substance that is designed to impede the immediate release of the active and/or inert ingredient(s)
A solid composed of small particles or grains and have been coated with a substance that is designed to impede the immedia
A pharmaceutical dosage form comprised of delayed release granules designed to form a suspension.
A tablet composed of individual fragments have been coated with a substance that is designed to impede the immediate rele
A capsule composed of active and/or inert ingredient(s) small, spherical structures that have been coated with a substance th
A tablet that has been coated with a substance that is designed to impede the immediate release of the active and/or inert in

A resinous film-forming agent dissolved in a solvent or a calcium hydroxide suspension within a synthetic resin solution, whic
A gel intended for use in the oral cavity to clean the teeth and maintain oral hygiene.
A paste of mild abrasives, detergents, flavoring agents, binders, fluoride, and other active and/or inert ingredient(s).
A powder composed of a mild abrasives, detergents, flavoring agents, binders, fluoride, and other active and/or inert ingredie

A container, usually made of glass or metal, that has at least two walls with the space between each wall evacuated so as to p
A dose pack container designed to assist with patient compliance. The patient turns a dial to the correct day and the correct d
A flat, circular shaped form composed of a solid or powder that contains active and/or inert ingredient(s).
A bottle that is used by the pharmacist to dispense the prescribed medication. It includes preparations for which a dropper ac
A vial that is used by the pharmacist to dispense the prescribed medication.
A substance intended for administration as a solution.
A substance intended for administration as a suspension.
An indication that the dosage form is not relevant or appropriate.
A container in which a preselected dose or dose regimen of the medication is placed.
A substance intended for use as a vaginal irrigant.
A substance intended for administration in or on a wound.
A solution intended for administration in a drop-wise fashion.
A suspension intended for administration in a drop-wise fashion.
A bottle that has a device specifically intended for the application of a liquid in a drop by drop manner, or a device intended f
Modern technology, distributed with or as a part of a drug product that allows for the uniform release or targeting of drugs to
A packaged set of related pharmaceutical or and/or drug delivery devices used for a particular medical activity or procedure i
The drug product container with any accompanying materials or components. This may include the protective packaging, labe
A granule composed of active and/or inert ingredient(s), and a mixture of acids and sodium bicarbonate, which release carbo
A powder composed of active and/or inert ingredient(s), and a mixture of acids and sodium bicarbonate, which release carbo
A tablet composed of active and/or inert ingredient(s), and a mixture of acids and sodium bicarbonate, which release carbon
A patch that composed of active and/or inert ingredient(s) whose release is controlled by electronic impulses that release ing
A solution composed of a clear, sweetened hydroalcoholic liquid in which active and/or inert ingredient(s) are dissolved.
A semi-solid composed of at least two immiscible liquids, one of which is dispersed as droplets within the other liquid, and sta
An emulsion intended for injection.
A solution or suspension intended for administration into the rectum.
A solid in the shape of a small sphere intended to be embedded securely in the body and designed to release active and/or in
A capsule designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequen
A capsule covered with a thin layer of substance and is designed to release active and/or inert ingredient(s) at a controlled, p
A pellet covered with a thin layer of substance that is designed to release active and/or inert ingredient(s) at a controlled, pro
A solid or liquid core composed of active and/or inert ingredient(s) enclosed by a polymer coated shell. It is designed to relea
A substance that forms a suspension upon reconstitution and designed to release active and/or inert ingredient(s) at a contro
A solid in the shape of a slender, elongated thread that is designed to release active and/or inert ingredient(s) at a controlled
A capsule covered with a thin layer of water soluble or insoluble polymer and is designed to release active and/or inert ingred
A film that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequ
A solution that becomes gelatinous upon administration and is designed to release active and/or inert ingredient(s) at a contr
A solid in the shape of a small particle or grain designed to release active and/or inert ingredient(s) at a controlled, prolonged
A granule intended for administration as a suspension and designed to release active and/or inert ingredient(s) at a controlle
An insert designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequenc
A pharmaceutical dosage form comprised of extended release agents for intraruminal administration.
A solution or suspension that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to r
A patch designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency
A suppository that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosi
A suspension that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosin
A tablet designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency
A distillate composed of active and/or inert ingredient(s) extracted from plant or animal matter, and represented in concentr
Having undergone failure; did not accomplish the intended purpose.
A tablet covered with a thin layer of water soluble or insoluble polymer and is designed to release active and/or inert ingredie
A tablet covered with a thin layer of water soluble or insoluble polymer.
A thin layer of water soluble or insoluble polymer intended to coat the site of administration.
A container with a base wider than the narrow neck traditionally used for holding liquids.
A receptacle with a body constructed of film, woven plastic, woven fabric, paper or combination thereof, together with any a


A container designed specifically to hold gases.
An elastic aeriform fluid in which the molecules are separated from one another and have freedom of movement.
A semi-solid composed of a solid, three dimensional, cross linked matrix of polymers within a liquid, yielding a jelly-like mater
A solution intended for administration in a drop-wise fashion; it becomes gelatinous upon administration.
A capsule covered with a thin layer of gelatin.
An apparatus that converts solutions, suspensions or solids, composed of active and/or inert ingredient(s) into a vapor or gas
A glass vessel with a narrow neck designed to accept a specific closure.
A device for the administration of parenteral drug products that consists of a rigid glass barrel fitted with septum with a plung
A glass container designed for use with parenteral drug products.
A solid composed of sucrose, lactose or other polysaccharides formed into small globular pellets impregnated with active and
A solid composed of a piece of skin or other tissue intended for implantation into or on the body.
A solid composed of small particles or grains.
A granule intended for administration as a solution.
A granule intended for administration as a suspension.
A statement about the relative size or order of two objects specifying that an object of interest exceeds another object in qua
A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or me
A semi-solid composed of a sticky, mucilaginous polysaccharide.

A premarket submission to FDA for a device intended to benefit patients by treating or diagnosing a condition affecting fewer


A solid intended for insertion securely within the body.
A pellet intended for insertion securely within the body.
Vaporized active and/or inert ingredient(s) intended for administration by inhalation.
A device by means of which a medicinal product can be administered by inspiration through the nose or the mouth.
A container of medication intended to refill an inhaler.
A substance intended for injection.
A suspension intended for injection that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rat
A substance composed of complexed active and/or inert ingredient(s) with natural or synthetic lipids that is intended for inje
A suspension composed of active and/or inert ingredient(s) encapsulated in liposomes and intended for injection.
A solution intended for injection.
A suspension intended for injection and is sonicated while a gas is bubbled through the suspension resulting in the creation o
A suspension intended for injection.
A solid or semi-solid intended for administration within the body.
A solid intended for placement within the uterine cavity where active and/or inert ingredient(s) are released from an apparat
Allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to supp


A solution or suspension used to bathe or flush open wounds or body cavities.
A rigid container having a wide mouth and often no neck which typically holds solid or semisolid drug products.
A semi-solid composed of suspensions of active and/or inert ingredient(s) in any type of highly viscous material, including gel
A large, deep container that has a narrow mouth, is typically fitted with a handle, and is used to hold liquids.
A collection of unrelated materials that are used together to orchestrate dosage administration.
A statement about the relative size or order of two objects specifying that an object of interest is smaller than another object
A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or me
A round container that has an inner layer of a material different from what the canister is composed of.

A semi-solid with viscosity similar to that of a lotion, which is intended for topical use and must be rubbed into the site of adm
A substance composed of active and/or inert ingredient(s) encapsulated in liposomes and intended for injection.
A solid or semi-solid with a waxy consistency in the shape of a stick and intended for use on the lips.
A substance in the fluid state of matter having no fixed shape but a fixed volume.
A capsule composed of liquid covered with an outer shell, which is usually prepared from gelatin.
A semi-solid composed of an oil in water emulsion, with lower viscosity than cream or gel.
A lotion composed of anionic surfactant intended for administration to the hair or scalp.
A solid composed of active and/or inert ingredient(s), sweeteners, other flavorings and mucilage, intended for oral administra

A pharmaceutical dosage form comprised of lyophilized powder.
A freeze dried powder intended for injection following reconstitution with a suitable solvent to form a suspension that is desi
A freeze dried powder composed of active and/or inert ingredient(s) encapsulated in liposomes and intended for injection fo
A freeze dried powder intended for injection following reconstitution with a suitable solvent to form a solution.
A freeze dried powder intended for injection following reconstitution with a suitable solvent to form a suspension.
An aerosol contained in a device with valves that permits the release of a specified quantity of active and/or inert ingredient(
A gel contained in a device with valves that permits the release of a uniform dose of gel that composed of active and/or inert
A powder contained in a device with valves that permits the dispensing of active and/or inert ingredient(s) upon activation.
A spray contained in a device with valves that permits the dispensing of a specified quantity of active and/or inert ingredient(
A flat dish type device with multiple wells for testing cellular material.
A solution or suspension intended for oral administration, for its deodorizing or antiseptic effects in the oral cavity. Usually, th
A vial intended to contain more than one dose of the drug product.
A tablet composed of active and/or inert ingredient(s) that have been compressed into multiple layers and is designed to rele
A tablet composed of active and/or inert ingredient(s) that have been compressed to form a tablet that contains multiple lay




Determination of a value is not relevant in the current context.
A solution or suspension that is hydrophobic, soluble in organic solvents, and liquid at ambient temperature.
A semi-solid, viscous in texture, that may be composed of a variety of bases including hydrocarbons, emulsifiers or vegetable
A tablet that disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue but is also designed to im
A tablet which disintegrates and dissolves quickly (usually within a matter of seconds) in the mouth. Additional water to comp
The package type is not stated or is unavailable.
A receptacle for holding something (e.g., that into which some oral contraceptive blister packs are placed).
A straight-sided cylindrical shipping container with flat ends; one of which can be opened/closed.
A large receptacle used for holding, transporting, or storing liquids or gases, and often referred to as a reservoir.
A flexible container for semisolid drug products which is flattened and crimped or sealed at one end and has a reclosable ope
An envelope into which only one dose of a drug product, usually in the form of granules or powder, has been directly placed.
A solid composed of a material that contains active and/or inert ingredient(s) which is intended to be placed in a cavity or dep
A watertight vessel, often cylindrical, that is usually fitted with a handle, and that may have a lid.
A container designed for use with parenteral drug products.
One of two possible results of a pass/fail assessment; when the result satisfies a condition.
A semi-solid composed of a large proportion of solids and finely dispersed active and/or inert ingredient(s) in a fat-based veh
A solid or semi-solid composed of a lozenge, that contains active and/or inert ingredient(s) that dissolves when sucked in the
A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingre
A solid composed of an impermeable occlusive backing and a formulation matrix in which the active and/or inert ingredient(s
A vial that has a patented delivery system.
A solid composed of a small granular or compressed mass that contains highly purified active and/or inert ingredient(s).
A pharmaceutical dosage form containing active substance(s) delivered via pendant.
A shallow dish with a lid used to culture cells.
A container of a sterile preparation whose contents are intended for use in a pharmacy admixture program and are restricted


A vial that contains a parenteral preparation that can be attached directly to the tubing of a parenterally administered fluid.
A solid composed of a small, round object composed of active and/or inert ingredient(s).
A semi-solid composed of a soft, smooth mass with relatively thick consistency and strong adhesiveness that becomes solid w
A plastic vessel with a narrow neck designed to accept a specific closure.
A device for the administration of parenteral drug products that consists of a rigid plastic barrel fitted with septum with a plu
A plastic container designed for use with parenteral drug products.
A flexible container used to protect or hold one or more doses of a drug product (e.g. a pouch into which oral contraceptive b
A semi-solid composed of a soft, moist mass that is made by wetting an absorbent solid substance.
A powder composed of active and/or inert ingredient(s) and packaged under pressure. Ingredients are released upon activati
A solid composed of a mixture of dry, finely divided active and/or inert ingredient(s).
A powder intended for injection following reconstitution to form a suspension that is designed to release active and/or inert
A powder intended for injection following reconstitution to form a solution.
A powder intended for injection following reconstitution to form a suspension.
A powder that yields a solution following reconstitution with an appropriate liquid.
A powder that forms a suspension when reconstituted with a liquid solution.

A premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective as a legall




A bottle that is fitted with a pumping mechanism for the administration of drug product.




A semi-solid composed of a mixture of gum and a plant based hydrocarbon.
A solid composed active and/or inert ingredient(s) of in the shape of a hoop.
A solution or suspension intended for irrigation purposes.

A semi-solid composed of a thick, fat or wax-based ointment or cerate with a consistency somewhere between an ointment a
A solution or suspension composed of an anionic surfactant and intended for administration to the hair and/or scalp.
A suspension composed of anionic surfactant and intended for administration to the hair and/or scalp.
A vial containing a single unit of a parenteral drug product.
A vial where a single dose of a parenteral drug product can be removed, and then the vial and its remaining contents can be d
A pharmaceutical dosage form comprised of paper that is smoked.
A pharmaceutical dosage form comprised of a stick that is smoked.


An anionic surfactant for cleansing.
A film that will dissolve in a liquid solvent to form a solution.
A tablet that will dissolve in a liquid solvent to form a solution.
A clear, homogeneous liquid composed of one or more chemical substances dissolved in a solvent or mixture of mutually mis
A solution composed of an iced saline slurry with or without active and/or inert ingredient(s) intended to induce regional hyp
A solid composed of a porous, interlacing, absorbent, usually shape retaining material, such as cellulose wood fibers or plastic
A bottle that is fitted with an atomizer or a device which produces finely divided liquid carried by air.
A solution or suspension composed of active and/or inert ingredient(s) in oil or water, typically dispensed from an atomizer o
A spray composed of a suspension that contains active and/or inert ingredient(s).
Terminology developed to support Closure Systems within the Stability Data Standards.
Terminology developed to support Container Types within the Stability Data Standards.
Terminology developed to support Product Forms within the Stability Data Standards.
Terminology developed to support Product Identifiers within the Stability Data Standards.
Terminology developed to support Data File Reasons within the Stability Data Standards.
Terminology developed to support Data File Types within the Stability Data Standards.
Terminology developed to support Study Interpretations within the Stability Data Standards.
Terminology developed to support Study Method Types within the Stability Data Standards.
Terminology developed to support Pause Descriptions within the Stability Data Standards.
Terminology developed to support Storage Conditions within the Stability Data Standards.
Terminology developed to support Study Tests within the Stability Data Standards.
Terminology developed to support Study Types within the Stability Data Standards.
Terminology developed to support Substance Identifiers within the Stability Data Standards.

A solid composed active and/or inert ingredient(s) in a long, slender cylindrical shape.

A solid composed of active and/or inert ingredient(s) in a long narrow piece of material.
A tablet covered with sugar.
A multilayer paper bag for shipping some solid bulk excipients, usually in the form of powder or granules.
A solid or semi-solid composed of active and/or inert ingredient(s) in a wax, fat or a glycerin gelatin jelly and that is conical or
Insoluble solid particles composed of active and/or inert ingredient(s) that are dispersed in a liquid.
A solid composed of fibrous strands of material that are used to bind wound edges together.
A solid composed of a small piece of absorbent material attached to one end of a small stick.
A device for the administration of parenteral drug products that consists of a rigid barrel fitted with septum with a plunger at
A solution or suspension composed of a viscid vehicle that contains a high concentration of sucrose or other sugars and active
A tablet composed of a conglomerate of particles that contains active and/or inert ingredient(s) that have been individually c
A solid composed of a mixture of that active and/or inert ingredient(s) are pressed or compacted together, usually in the form
A tablet that changes into a solution when added to a liquid solvent.
A tablet that changes into a suspension when added to a liquid solution.
A specialized package; it registers each time it is opened and is used for checking patient compliance to prescribed medicatio
A pharmaceutical dosage form containing active substance(s) that are delivered via a tag device.




A solid composed of a plug made from absorbent material.
A solid composed of narrow woven fabric or a narrow extruded synthetic material, usually with an adhesive on one or both s

A solution composed of an alcoholic extract or solution of nonvolatile active and/or inert ingredient(s).

A shallow flat receptacle, with a raised edge or rim, used for carrying, holding, or displaying finished drug product in its prima

A solid discoid composed of active and/or inert ingredient(s) in a suitably flavored base, that dissolves when sucked in the mo

An indication that the dosage form has yet to be assigned.
A bottle that contains a single whole dose of a non-parenteral drug product.
A box that contains a single dose of a non-parenteral drug product. [Note: Boxes that contain 100 unit dose blister packs shou
A cup intended to hold a single dose of a non-parenteral drug product.




A dome-shaped insert with a springy, flexible rim intended to be inserted into the vagina and positioned behind the pelvic bo

A solid composed of a thin slice of material that contain active and/or inert ingredient(s).
Stability Preferred Term


AEROSOL
AEROSOL, FOAM
AEROSOL, SPRAY
Delayed, Ambient
AMPULE
Annual Report
APPLICATOR
BOTTLE, WITH APPLICATOR
TUBE, WITH APPLICATOR
Supplement to an Approved Application
CREAM, AUGMENTED
LOTION, AUGMENTED
OINTMENT, AUGMENTED
BAG
BEAD
Biological
Biologics License Application
BLISTER PACK
BLOCK
BOTTLE
BOX
CAN
CANISTER
CAPSULE
CAPSULE
CARTON
CARTRIDGE
CELLO PACK
CEMENT
Chemical
BAR, CHEWABLE
TABLET, CHEWABLE
GUM, CHEWING
Child-resistant, Metal
Child-resistant, Plastic
CIGARETTE
Clinical
CLOTH
CAPSULE, COATED
CAPSULE, COATED PELLETS
TABLET, COATED
CFR Regulation
PACKAGE, COMBINATION
Commercial
Compendial
CONCENTRATE
INJECTION, SOLUTION, CONCENTRATE
SOLUTION, CONCENTRATE
CONE
CONTAINER
Continuous Thread, Metal
Continuous Thread, Plastic
CREAM
Crown, Metal
CRYSTAL
CUP
Cycled
CAPSULE, DELAYED RELEASE
GRANULE, DELAYED RELEASE
GRANULE FOR SUSPENSION, DELAYED RELEASE
TABLET, DELAYED RELEASE PARTICLES
CAPSULE, DELAYED RELEASE PELLETS
TABLET, DELAYED RELEASE
Delayed
LINER, DENTAL
GEL, DENTIFRICE
PASTE, DENTIFRICE
POWDER, DENTIFRICE
Development
DEWAR
DIALPACK
DISC
BOTTLE, DISPENSING
VIAL, DISPENSING
FOR SOLUTION
FOR SUSPENSION
NOT APPLICABLE
DOSE PACK
DOUCHE
DRESSING
SOLUTION/DROPS
SUSPENSION/DROPS
BOTTLE, DROPPER
DRUG DELIVERY SYSTEM
KIT
PACKAGE
GRANULE, EFFERVESCENT
POWDER, EFFERVESCENT
TABLET, EFFERVESCENT
PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED
ELIXIR
EMULSION
INJECTION, EMULSION
ENEMA
BEAD, IMPLANT, EXTENDED RELEASE
CAPSULE, EXTENDED RELEASE
CAPSULE, COATED, EXTENDED RELEASE
PELLETS, COATED, EXTENDED RELEASE
CORE, EXTENDED RELEASE
FOR SUSPENSION, EXTENDED RELEASE
FIBER, EXTENDED RELEASE
CAPSULE, FILM COATED, EXTENDED RELEASE
FILM, EXTENDED RELEASE
SOLUTION, GEL FORMING, EXTENDED RELEASE
GRANULE, EXTENDED RELEASE
GRANULE, FOR SUSPENSION, EXTENDED RELEASE
INSERT, EXTENDED RELEASE
INTRARUMINAL DEVICE, EXTENDED RELEASE
LIQUID, EXTENDED RELEASE
PATCH, EXTENDED RELEASE
SUPPOSITORY, EXTENDED RELEASE
SUSPENSION, EXTENDED RELEASE
TABLET, EXTENDED RELEASE
EXTRACT
FAILED
TABLET, FILM COATED, EXTENDED RELEASE
TABLET, FILM COATED
FILM
Flask
FLEXIBLE INTERMEDIATE BULK CONTAINER
Flip-Top (Dispensing), Plastic
Delayed, Frozen
CYLINDER
GAS
GEL
SOLUTION, GEL FORMING/DROPS
CAPSULE, GELATIN COATED
GENERATOR
BOTTLE, GLASS
SYRINGE, GLASS
VIAL, GLASS
GLOBULE
GRAFT
GRANULE
GRANULE, FOR SOLUTION
GRANULE, FOR SUSPENSION
MT
NLT
GUM
Hinged (Dispensing), Plastic
Humanitarian Device Exemption (HDE)
ICH
Immediate
IMPLANT
PELLET, IMPLANTABLE
INHALANT
INHALER
INHALER, REFILL
INJECTION
INJECTION, SUSPENSION, EXTENDED RELEASE
INJECTION, LIPID COMPLEX
INJECTION, SUSPENSION, LIPOSOMAL
INJECTION, SOLUTION
INJECTION, SUSPENSION, SONICATED
INJECTION, SUSPENSION
INSERT
INTRAUTERINE DEVICE
Investigational Device Exemption
Investigational New Animal Drug File
Investigational New Drug Application
IRRIGANT
JAR
JELLY
JUG
KIT
LT
NMT
Canisters, lined
Linerless, Plastic
LINIMENT
INJECTABLE, LIPOSOMAL
LIPSTICK
LIQUID
CAPSULE, LIQUID FILLED
LOTION
LOTION/SHAMPOO
LOZENGE
Lug, Metal
POWDER, LYOPHILIZED
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE
INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
AEROSOL, METERED
GEL, METERED
POWDER, METERED
SPRAY, METERED
Plate, Microwell
MOUTHWASH
VIAL, MULTI-DOSE
TABLET, MULTILAYER, EXTENDED RELEASE
TABLET, MULTILAYER
New Active Ingredient
New Animal Drug Application
New Drug Application
NA
OIL
OINTMENT
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
TABLET, ORALLY DISINTEGRATING
NOT STATED
CASE
DRUM
TANK
TUBE
PACKET
PACKING
PAIL
VIAL
PASSED
PASTE
PASTILLE
PATCH
PATCH
VIAL, PATENT DELIVERY SYSTEM
PELLET
PENDANT
Dish, Petri
VIAL, PHARMACY BULK PACKAGE
Photostability
Physical
VIAL, PIGGYBACK
PILL
PLASTER
BOTTLE, PLASTIC
SYRINGE, PLASTIC
VIAL, PLASTIC
POUCH
POULTICE
AEROSOL, POWDER
POWDER
INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE
INJECTION, POWDER, FOR SOLUTION
INJECTION, POWDER, FOR SUSPENSION
POWDER, FOR SOLUTION
POWDER, FOR SUSPENSION
Premarket Approval
Premarket Notification 510(K)
Press-on/twist-off, Metal
Press-on, Composite
Proprietary
Proprietary
BOTTLE, PUMP
Pump (Dispensing), Plastic
Push-pull (Dispensing), Plastic
Delayed, Refrigerate
GUM, RESIN
RING
RINSE
Roll-on, Metal
SALVE
SHAMPOO
SHAMPOO, SUSPENSION
VIAL, SINGLE-DOSE
VIAL, SINGLE-USE
SMOKE PAPER
SMOKE STICK
Snap-on Cap, Plastic
Snip-tip (Dispensing), Plastic
SOAP
FILM, SOLUBLE
TABLET, SOLUBLE
SOLUTION
SOLUTION, FOR SLUSH
SPONGE
BOTTLE, SPRAY
SPRAY
SPRAY, SUSPENSION
Stability Container Closure System Terminology
Stability Container Type Terminology
Stability Product Form Terminology
Stability Product Identifier Terminology
Stability Study Data File Reason Terminology
Stability Study Data File Type Terminology
Stability Study Interpretation Terminology
Stability Study Method Type Terminology
Stability Study Pause Description Terminology
Stability Study Storage Condition Terminology
Stability Study Test Terminology
Stability Study Type Terminology
Stability Substance Identifier Terminology
Standard
STICK
Stopper
STRIP
TABLET, SUGAR COATED
SUPERSACK
SUPPOSITORY
SUSPENSION
SUTURE
SWAB
SYRINGE
SYRUP
TABLET, COATED PARTICLES
TABLET
TABLET, FOR SOLUTION
TABLET, FOR SUSPENSION
TABMINDER
TAG
Tamper-evident, Composite
Tamper-evident, Metal
Tamper-evident, Plastic
TAMPON
TAPE
Tie
TINCTURE
Toggle-swing (Dispensing), Plastic
TRAY
Trigger Sprayer (Dispensing), Plastic
TROCHE
Twist Open/Close (Dispensing), Plastic
UNASSIGNED
BOTTLE, UNIT-DOSE
BOX, UNIT-DOSE
CUP, UNIT-DOSE
Vacuum, Composite
Vacuum, Metal
Vacuum, Plastic
DIAPHRAGM
Valved (Dispensing), Plastic
WAFER
WHO
Stability Definition




Sample is stored at ambient conditions and not tested immediately.

Stability data submitted to an annual report or update to an approved application.




Stability data submitted to an approved application already filed with the FDA.




Biological measurement or determination.
Stability data submitted to a biologics license application.




Chemical measurement or determination.




Metal closure that is designed or constructed to be significantly difficult for children under five years of age to open and not d
Plastic closure that is designed or constructed to be significantly difficult for children under five years of age to open and not

Stability data for a clinical lot.




Method dictated by CFR.

Stability data for a commercial lot.
Official compendial method.




Metal closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal.
Plastic closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal.

A non-threaded shallow draw metal closure that normally has 21 corrugations on the outer edge, which function to engage th


A Cycled study would be a one time freeze/thaw study.




Sample is not tested immediately.




Stability data for a developmental lot.
This is equivalent to does not meet requirements or specifications.




Flat bottom bottle, container or vessel.

A hinged single or dual flap closure for controlled product dispensing.
Sample is frozen and not tested immediately.




The value should not be smaller than the given value excluding the given value, which is equivalent to "greater than".
The value should not be smaller than the given value and includes the given value, which is equivalent to "greater than or equ
A closure with a lid that is hinged to the top of a closure and opens to expose a dispensing orifice.
Stability data submitted for an HDE application.
ICH storage temperature, Q1A-Q1F.
Sample is tested immediately.




Stability data submitted to an investigational device exemption.
Stability data submitted to an investigational new animal drug file.
Stability data submitted to an investigational new human drug application.




The value should not be greater than the given value excluding the given value, which is equivalent to "less than".
The value should not be greater than the given value and includes the given value, which is equivalent to "less than or equal t
A type of lined can for holding a drug product.
A closure that incorporates a specific molded-in feature such as rings, plugs or flexible sections. These features achieve a seal




Closure with an ability to be applied and removed with a partial turn. The closure can also be produced with vacuum buttons
Small volume multi-chambered plate (e.g. 96 well).




Stability data submitted for an active ingredient, could be stability data for an active ingredient submitted in a drug applicatio
Stability data submitted to a new animal drug application.
Stability data submitted to a new human drug application.
If a value for test has to be provided, but has no given criteria (e.g., the result is for "report only" or "monitoring").




This is equivalent to meets requirements or specifications.




A shallow dish with a loose-fitting cover.

A Photostability study would be a one time study.
Physical measurement or determination.
Stability data submitted for a PMA application.
Stability data submitted for a premarket 510(k) submission.
Closure with a stepped, skirted drawn shell with an inside curl. The closure is lined with an annular plastisol material designed
A metal/plastic composite cap composed of a plastisol lined metal disk, assembled to a plastic band. The closure requires a si
Company method.
Company defined.

Closure dispensing pumps are used to dispense product from containers.
A two-piece dispensing closure that includes a base member the lower portion of which is designed to attach and seal secure
Sample is refrigerated and not tested immediately.




A tamper-evident closure produced as an unthreaded shell containing a liner. It is applied to the proper finish on a plastic or g




A non-threaded closure that is pressed onto the package finish with a protruding feature that mates with a similar protruding
Conical closure that is turned onto a container. The tip is cut off to open the container.




The closure system of the container.
As reported entity or as part of a reported packaged product, this is the official code for a referenced package type. For FDA i
This code describes the form of the reported product. Code values might be provided if available (e.g., when used in other su
This is the code for the official product name. For FDA implementation, only the "displayName" (i.e., the product name) is ma
This code should indicate the type of application the data supports or whether the data is submitted to an existing application
This code should reflect if the file in hand is a standard data file for one storage condition or a partial file as part of a cycled st
For a single acceptance criterion (i.e., limit) this code describes how to relate the given value to a measured value, (e.g., a res
A classification of the methods used in stability testing.
This code describes any delay that happened during testing, e.g. none (Immediate) or freeze sample (Delayed Frozen).
The code provided represents a storage condition. Dependent of the internal company definitions this condition might be sim
This code describes the test performed during a study within the specification sheet.
This code classifies the type of study performed on the given Research Subject, e.g., Commercial, Development, Clinical.
The official code for a referenced substance (e.g., acetylsalicylic acid), as a single entity or part of a product (e.g., aspirin). For
A Standard stability study would be a long term or accelerated stability study for either a finished product or active ingredien

Object used to plug opening of container.




Composite tamper-evident closures usually consist of a metal disk with a plastic skirt. The plastic skirt is perforated or weaken
A closure/finish of a closure/container system designed to make it difficult to achieve the first removal of a closure from a co
A closure that shows the package has been opened and the product has been exposed to the outside environment.


Line, ribbon, or cord used for fastening, or drawing the container closed.

A closure with a lower part attaches securely and seals the container. The upper part provides a second movable portion whi

Closure designed to dispense product from containers by spraying the product when a trigger is pulled.

Two-piece dispensing closure that has a lower portion designed to attach and seal securely to a container finish and the uppe




Metal/Plastic closures used on packages where the pressure inside the package is less than atmospheric.
Metal closures used on packages where the pressure inside the package is less than atmospheric.
Plastic closures used on packages where the pressure inside the package is less than atmospheric.

Dispensing closure incorporating a product-flow controlling valve within the orifice. Product will not dispense from the packa

WHO Technical Report Series, No.953, 2009. Stability testing of active pharmaceutical ingredients and finished pharmaceutica
of age to open and not difficult for normal adults to use properly.
of age to open and not difficult for normal adults to use properly.
glass, plastic or metal.
glass, plastic or metal.

ch function to engage the container when applied. The crown is only 1/4" high when manufactured and does not have a rolled edge or w
 "greater than".
t to "greater than or equal to".
 "less than".
t to "less than or equal to".

 features achieve a seal by conforming to one or more of the sealing surfaces on the container neck finish.




d with vacuum buttons that can clearly indicate to the packer if a vacuum has been effectively drawn following the closure application.
tted in a drug application, or a Master File.


monitoring").
astisol material designed to provide a proper seal along the top and side surfaces of the glass container finish. The closure uses a special p
The closure requires a simple glass bead finish common on bowls, tumblers and carafes.




o attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. The spo




er finish on a plastic or glass container by the bottler, using a roll-on capping machine that forms a thread in the closure matching the bot




with a similar protruding feature on the closure to secure the closure to the package.




 package type. For FDA implementation, only the display Name (i.e., the product name is mandatory, the code values might be provided if
 , when used in other submissions like SPL).
 he product name) is mandatory, the code values might be provided if available (e.g., when used in other submissions like SPL). For NDA th
 o an existing application. The codes indicate that the data is part of an Annual Report, New Drug Application, New Active Ingredient, Biolo
file as part of a cycled study.
asured value, (e.g., a result should not be greater (not more) than the given value). The common accepted nomenclature should be used h

Delayed Frozen).
s condition might be simple (e.g., 25 degrees) or complex (e.g., 25 degrees C/60% R.H. upright).
elopment, Clinical.
oduct (e.g., aspirin). For FDA implementation, only the displayName (i.e. the product name) is mandatory, the code values might be provi
duct or active ingredient.




 is perforated or weakened in some manner so that when the closure is removed, this section is designed to break and either remain on t
al of a closure from a container without it being detectable by subsequent users that the package seal has been breached (e.g., aluminum
 environment.




nd movable portion which functions in a rocker-like pivotal motion between an open and a closed position.




iner finish and the upper portion of which is designed to receive a dispensing spout member. Rotating the spout member opens and close




 ispense from the package until sufficient squeezing pressure is applied to the flexible container to cause the valve to open.

d finished pharmaceutical products.
does not have a rolled edge or wire. The crown is manufactured in 26mm worldwide and can be applied to either a threaded finish or a s
llowing the closure application.
inish. The closure uses a special plastisol material that, following application, takes a permanent impression of the glass threads ensuring




spensing spout member. The spout member may be moved upward and downward to open and close the dispensing passageway.




d in the closure matching the bottle thread.




e code values might be provided if available).

r submissions like SPL). For NDA this is a new identifier. For ongoing studies the identifier should be identical to an already submitted cod
ation, New Active Ingredient, Biologics License Application, Premarket Approval, or Supplement to an Approved Application.

ed nomenclature should be used here.
 y, the code values might be provided if available (e.g., when used in other submissions like SPL), please refer to Substance Registration Sy




 d to break and either remain on the container or attached to the closure to indicate the package has been opened.
as been breached (e.g., aluminum overseal).




he spout member opens and closed the container.




e the valve to open.
d to either a threaded finish or a solid ring pry-off finish.
sion of the glass threads ensuring cam-off and reseal.




he dispensing passageway.




ntical to an already submitted code, so that a unique relationship can be established.
pproved Application.
refer to Substance Registration System - Unique Ingredient Identifier (UNII), at http://www.fda.gov/oc/datacouncil/spl.html. If you have a
datacouncil/spl.html. If you have a new compound that is not in the Substance Registration System (SRS) it can be registered by contactin
) it can be registered by contacting fda-srs(at)fda.hhs.gov. The compound can be given a code and the other information about the compo
ther information about the compound can remain confidential.

								
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