Betamethasone 0 1pc cream by 7m4ysl36

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									Batch Record                                                     Page 1 of 2                                         Revision Nr. 1
                                                                                                               8/8/2012 of Outprint
  Batch Record (tentative)                               Label: Compounder          PHARMACY NAME               Batch-Nr.
   Product-Nr.                                                                      BETAMETHASONE CREAM
   Date planned 17/03/11                                 Product name/Conc.         As valerate 0.1% 20 mg = 20 g
   Date started                                          Total quant./Vol./Form   (2.55 micromol/g) 1 mg / g
   Batch size          1000        GM                                             Glucocorticoid in hydrophilic base
   Batch quantity        50        Items of      20 GM                            Not for prolonged use
   Density        1.000000           (for calculation)                            Preserv. 9.5% w/w propylene glycol
   Shelf life            12        Months                             Expiry Date Extern.use        Exp.Date 17/03/12

  Composition                                      Factor:      1.0000                              Weighed Checked
  Ingredients       Prod.Check by N.N.                      Quantity                     Lot Number By N.N. By N.N.
   A    2152-44-5             Betamethasone valerate micronised    1.20             GM
   B    73398-61-5            Medium chain triglycerides *)        5.00             GM
   C    5949-29-1             Citric acid monohydrate              0.28             GM
   D    6132-04-3             Trisodium citrate dihydrate          0.25             GM
   E    7732-18-51            Water purified                      49.50             GM
   F    Stock prod.           Basic cream DAC                   943.77              GM
        *) Coconut oil (CAS 8001-31-8) may ev.be used

  Sum of ingredients                                                      1000.00 GM

  Materials
                      Mat.Check by N.N.                         Piece(s)       Lot Number Checked by N.N.
   N         63665             Collapsible tubes lacquered inside (25g) 50 Pc
   P.        63045             Labels bright pink 50x30mm                52 Pc

  Processing                                                                             Adhere to   Carried    Checked
                                                                                         SOP Nr.     out by     By
        All procedures made under best possible aseptic conditions
        Prepare equipment to be utilized (disinfected with ethanol)
        Dissolve C and D in E
        Triturate A with B to obtain a homogeneous suspension
        Dilute the suspension AB with increasing amounts of F
        Add the citrate buffer solution CDE and mix together
        Immediately fill amounts of 20g into ointment tubes seal and label
        Equipment cleaning

        Units filled
        Reference & control samples
        Units 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
                                                                                                          8/8/2012 of Outprint



  Quality control
      Sensual tests                Aspect: soft cream                              Odourless
                                   Taste: not tested                               Colour: white

      Identity tests:
                 1 Betamethasone: see Nr. 3 below


      Physical & analytical data                        Minimum     Expected value Maximum         Measured
      Assay: see Nr. 1 below

        pH-value (indicator paper strip)                            Approx. 4

      Additional tests as requested         □                       □              □ other

      Result of quality control             Result:                 Date:               Signed




  Batch record reviewed
                      Batch accepted
                               Blocked                              Date:               Signed


      References (issued 06/2011)

       1. Monograph
          “Betamethasone Valerate Cream” USP 33, § 9.7 Nr. 10
       2. Formulation
          “Hydrophile Betamethasonvalerat Creme 0.1%” NRF Nr. 11.37 (in german) § 9.7 Nr.7
       3. Quality control
          WHO Basic Tests Pharm. Dosage Forms, 1991, pg. 26-27 (§ 9.5)
       4. Stability
          see Nr. 2 above
       5. Essential Medicines 17th ed. WHO Model List (March 2011)
           13.3 Antiinflammatory topical medicines
             □ Betamethasone Cream or Ointment: 0.1% (as valerate)
       6.1 Other monographs
          “Betamethasone Valerate Cream” BP 2011, § 9.7 Nr. 23
       6.2 Other formulations
          “Crème hydrophile à 0.121% de bétamethasone valérate” FTM (in french) § 9.4.1
          (buffered cetomacrogol cream, pH 5)




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

								
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