Electrode Gel by ro2Qcqg

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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.                                                                     ELECTRODE        Topical GEL
   Date planned 17/03/11                                Product name/Conc.       For ECG,EEG diagnosis       100 g
   Date started                                         Total quant./Vol./Form   Contains Sodium chloride 14% w/w
   Batch size          1000        GM                                            'in a hydrophilic gel (washable)
   Batch quantity        10        Items of 100 GM                               Preservative: 10% Propylene glycol
   Density        1.000000         (fixed) (eff.1.14)                            For external use only
   Shelf life            12        Months                            Expiry Date                    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    7647-14-51             Sodium chloride                             140.0   GM
   B    9004-62-0              Hydroxyethylcellulose 400                    50.0   GM
   C    57-55-6                Propylene glycol                            100.0   GM
   D    7732-18-51             Water purified                              710.0   GM

  Sum of ingredients                                                      1000.0 GM

  Materials
                      Mat.Check by N.N.                              Piece(s)           Lot Number Checked by N.N.
   N                           Glass jars clear 100ml                           10 Pc
   O                           Closures                                         10 Pc
   P.                          Labels bright pink 50x30mm                       12 Pc

  Processing                                                                            Adhere to   Carried   Checked
                                                                                        SOP Nr.     out by    By
        Prepare equipment to be utilized
        Mix C and D, then dissolve A
        Slowly add B in several portions under stirring
        Shake from time to time during 30 min
        'until a clear gel results
        Pour portions of 100 g into glass jars, add caps and seal
        Equipment cleaning and labelling

        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: transparent gel                          Odourless
                                   Taste: saline                                    Colourless

      Identity tests:
                 1 Sodium: Yellow colour of flame
                 2 Chloride: (dilute gel 1:10 with H2O) 1drop+1 drop dil.HNO3 +1 drop AgNO3→white precipitate

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

      Additional tests as requested

      Result of quality control             Result:                  Date:               Signed




  Batch record reviewed
                      Batch accepted
                               Blocked                               Date:               Signed

      References (issued 07/2011)

       1. Monograph
          “Elektrodengel” NRF 13.1 (in german) § 9.7 Ref.Nr. 7
       2. Formulation
          see Nr. 1 above
       3. Quality control
          sensual tests , see Nr. 1 above
       4. Stability
          tentative value
       5. Essential Medicines 17th ed. WHO Model List (March 2011)
          14. Diagnostic aid topical (not listed)
       6.1 Other monographs
           -
       6.2 Other formulations
          “Gel base conduttore per elettrodi” (in italian) § 9.7 Ref. Nr. 27, pg. 377
              (Hydroxyethylcellulose 3-4%)




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

								
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