Nifedipine 1 oral Susp by Z67gsK3j


									Batch Record                                                            Page 1 of 2                                              Revision Nr. 1
                                                                                                                          9/16/2012 of Outprint
  Batch Record (tentative)                                      Label: Compounder    PHARMACY NAME                 Batch-Nr.
   Product-Nr.                                                                       NIFEDIPINE        1mg=1ml Syringe
   Date planned 17/03/10                                    Product name/Conc.       Oral Paediatric Suspension (1)
   Date started                                             Total quant./Vol./Form       0.1%          (2.9 micromol/ml)
   Batch size           100 ML                                                         without conserving agents
   Batch quantity       100 Items of                   1 ML                          For single use only/Shake before use
   Density        1.001000                                                           Protect from light/store in cool place
   Shelf life              1 Month                                       Expiry Date ~10mOsm/L         Exp.Date 17/04/10

  Composition                              Factor:                                1.0000                       Weighed Checked
  Ingredients    Prod.Check by N.N.                                           Quantity              Lot Number By N.N. By N.N.
   A 21892-25-4           Nifedipine                                                0.100      GM
   B 9004-65-3(50)        Hypromellose 50mPa.s                                      1.000      GM
   C 7732-18-51           Water purified                                          99.000       GM
   D                                                                                    0
  Sum of ingredients                                                              100.10       GM

  Materials         Mat.Check by N.N.                                         Piece(s)              Lot Number Checked by N.N.
   N          63304          Infusion bottle glass 125ml                                   1   Pc
   O          63126          Rubber disk pink 37mmØ                                        1   Pc
   P.         63592          Screw cap f.perfusion bottle                                  1   Pc
   Q                         Syringes 2ml (PE/PP)                                        100   Pc
   R                         Caps for syringes                                           100   Pc
   S                         Black plastic bags                                          100   Pc
   T          63010          Labels white 50x30mm                                        204   Pc

  Processing                                                                                        Adhere to   Carried   Checked
                                                                                                    SOP Nr.     out by    By
     Prepare equipment to be utilized
     Wet B with the double amount (Bx2) of hot C (80-90°C)
     Add the rest of cold C (5°C) and mix
     Allow the mix to cool in ice water until thoroughly hydrated
     Fill the solution BC in infusion bottles, add caps and seal
     Sterilisation: 120°C / 20min
     Shake the bottle under cooling until a clear solution is obtained
  Important: The following processing under light protection
     Grind A with a small amount of BC
     Prepare a uniform paste by adding geometric amounts of BC
     until a homogeneous suspension results
     Fill portions of 1ml in syringes, add caps, labels
     Immediately pack the syringes in black plastic bags, label again
     Store in a cool place, clean equipment

        Bottles filled
        Bottles sterilised'clock
        Units defective
        Syringes filled
        Reference & control samples
        Syringes gained                                           Total =

        Describe ev.observed deviations:

  Compounding record reviewed:                                  Date:                               Signed:

Created by. Peter Frauch                                 Controlled and approuved by: N.N.
Date:...........................                              Date:..............................
Signature:                                                           Signature:
Batch Record                                                  Page 2 of 2                                              Revision Nr. 1
                                                                                                                9/16/2012 of Outprint

  Quality control
      Sensual tests                Aspect: opaque liquid                             Odourless
                                   Taste: not tested                                 Colour: yellowish

      Identity tests:
                 1 Nifedipine: see Monograph Int.Ph.for Nifedipine, Test C

      Physical & analytical data                       Minimum        Expected value Maximum             Measured

        PH-value (indicator paper)                              6.9            7.0                7.1

      Additional tests as requested

      Result of quality control             Result:                   Date:              Signed

  Batch record reviewed
                      Batch accepted
                               Blocked                                Date:              Signed

      References (issued 01/2012)
      1. Monograph
      2. Formulation
        2.1 "Enteral Suspension of nifedipine for neonates.Part 1. Formulation of nifedipine suspension
           for hospital use“ Helin-Tanninen al.,J.Clin.Pharm.Ther.(2001)26(1):49-57
        2.2 „Extemporaneous preparation of paediatric oral formulations: Studies conducted in nifedipine
          powders, capsules and suspensions in a hospital pharmacy“ Helin-Tanninen M. Lic.Thesis Pharm.
          Kuopio Uni.Hosp.Pharm.Dept.2008 (1.6MB)
         Important notice: If Hypromellose of another viscosity grade only is available, the concentration of this
         ingredient should be adjusted to obtain the viscosity desired.
      3. Quality Control
      - see 2.2 Additional data received from M.Helin-Tanninen (17.12.2010)
      4. Stability
         „Enteral suspension of nifedipine for neonates. Part 2. Stability of an extemporaneously
         compounded nifedipine suspension“ Helin-Tanninen al.J.Clin.Pharm.Ther.(2001)26(1):59-66
      5. Essential Medicines 16th ed. WHO Model List (March 2010)
         22.2 Nifedipine: (Immediate Release Capsules 10 mg)
      6.1 Other Monographs
      6.2 Other Formulations and stability data
        - „Stability of nifedipine in two oral suspensions stored at two temperatures“
          Nahata al.,J.Am.Pharm.Ass.(2002)42:865-867 (Used liquid from Nifedipine capsules)
        - „Stability of nifedipine in an extemporaneously compounded oral solution“
          Dentinger al. Am.J.Health-Syst.Pharm.(2003)60:1019-1022 (Sol.with PEG + Glycerine)
        - „Nifedipino soluciòn 1mg/ml“ (Sol.with PEG + Glycerine)
          (Download: )

Created by. Peter Frauch                         Controlled and approuved by: N.N.
Date:...........................                      Date:..............................
Signature:                                                   Signature:

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