Potass permanganate conc sol 1pc 100ml by HC120808073334

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									Batch Record                                                Page 1 of 2                                           Revision Nr. 0
                                                                                                            8/8/2012 of Outprint
  Batch Record (tentative)                          Label: Compounder      PHARMACY NAME               Batch-Nr.
   Product-Nr.                                                             POTASSIUM PERMANGANATE
   Date planned 17/03/11                          Product name/Conc.       Aqueous concentrated Solution
   Date started                                   Total quant./Vol./Form                 1%            100 ml
   Batch size          1000 ML                                             To be diluted before use
   Batch quantity        10 Items of       100 ML                          For external use only
   Density        1.005000                                                 Protect from light
   Shelf life            36 Months                             Expiry Date                    Exp.Date 17/03/14

  Composition                             Factor:                     1.0000                Weighed Checked
  Ingredients   Prod.Check by N.N.                                Quantity       Lot Number By N.N. By N.N.
   A 7722-64-7           Potassium permanganate                         10.00 GM
   B 7732-18-51          Water purified                               995.00 GM

  Sum of ingredients                                                   1005.00 GM

  Materials
                      Mat.Check by N.N.                       Piece(s)       Lot Number Checked by N.N.
   N                           Fluted amber glass bott. 100ml          10 Pc
   O                           Screw caps small                        10 Pc
   P.                          Labels white 50x30mm                    12 Pc
   Q                                                                      Pc
   R                                                                      Pc

  Processing                                                                          Adhere to   Carried   Checked
                                                                                      SOP Nr.     out by    By
        Prepare equipment to be utilized
        Dissolve A in freshly boiled and still warm B (under 50°C)
        under agitation
        Allow to cool to room temperature under agitation until dissolution
        is complete (e.g. magnetic stirrer over night)
        Filter over glass wool (not paper or metal filter)
        Fill portions of 100ml into glass bottles, add caps and seal
        Labelling
        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. 0
                                                                                                                   8/8/2012 of Outprint




  Quality control
      Sensual tests                Aspect: opaque solution                           Odourless
                                   Taste: not tested                                 Colour: deep violet red

      Identity tests:
                 1 Permanganate: see Nr. 3 below
                 2 Potassium: see Nr. 3 below


      Physical & analytical data                      Minimum         Expected value Maximum            Measured
       Refractive index
       E
       pH-value                                                 6.5            7.0                7.5

      Additional tests as requested        □                          □              □ other

      Result of quality control            Result:                    Date:              Signed




  Batch record reviewed
                      Batch accepted
                               Blocked                                Date:              Signed


      References (issued 07/2011)
      1. Monograph
         „Kaliumpermanganat-Lösungskonzentrat 1%“ NRF 11.82 (in german) Ref. § 9.7, Nr. 7
      2. Formulation
        see Nr. 1 above
      3. Quality control
        see Nr. 1 above (to be completed)
        for Identification see „Potassium permanganate“ BP 2011 (Tests A and B) § 9.7 Ref.Nr. 23
      4. Stability
        see Nr. 1 above (to be completed)
      5. Essential Medicines 17th ed. WHO Model List (March 2011)
         13.2 Anti-infective topical medicines. Potassium permanganate, aqueous solution: 1:10'000
      6.1 Other monographs
         -
      6.2 Other formulations
         6.2.1 „Potassium permanganate 1% stock solution for dilution“
            Bakker P.et al.“Dermatol.preparations for the tropics“ pg. 76-77, § 9.7 Ref.Nr. 30
         6.2.2 „Potassium permanganate sol. 5%“ Formulation 5.2-260
            „Préparations magistrales dermatologiques en Suisse“ (in french and german) § 9.4.1




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

								
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