Hydrochlorothiazide 5mg ml Oral Susp by G1A988C3


									Batch Record                                                            Page 1 of 2                                          Revision Nr. 0
                                                                                                                      9/30/2012 of Outprint
  Batch Record (tentative)                                      Label: Compounder          PHARMACY NAME              Batch-Nr.
   Product-Nr.                                                                              HYDROCHLOROTHIAZIDE 5mg/ml
   Date planned 17/03/11                                        Product name/Conc.       (0.5%)250mg= 50ml (17micromol/ml)
   Date started                                                 Total quant./Vol./Form   Oral suspension for paediatric use
   Batch size           500          ML                                                  (not for neonates) Tablet based,cons.
   Batch quantity        10          Items of        50 ML                               Methylparaben+K-sorbate 0.1% each
   Density        1.165000           tentative                                           Shake before use,protect from light
   Shelf life              2         Months                                  Expiry Date (~1735mOsm/Lt) Exp.Date 17/05/11

  Composition                                     Factor:         1.0000                                 Weighed Checked
  Ingredients    Prod.Check by N.N.                           Quantity                        Lot Number By N.N. By N.N.
   A Stock prod.            Hydrochlorothiazide tabl. 25Mg          100.0                  Pc *)
   B             (gross weight: GM/tablet =             0.140       14.00                  GM
   C Stock prod.            Vehicle for oral susp.sugarfree       250.00                   GM
   D Stock prod.            Vehicle for oral sol.sugar based      250.00                   GM
   E Stock prod.            Vehicle for oral sol.sugar based        68.50                  GM
     *) number of tablets equivalent to the amount of
                            Hydrochlorothiazide required
  Sum of ingredients                                              582.50                   GM

                       Mat.Check by N.N.                                     Piece(s)           Lot Number Checked by N.N.
   N          63606             Bottle amber glass 50ml                                 10 Pc
   O          63363             Screwcaps small                                         10 Pc
   P.         63010             Labels white 50x30mm                                    12 Pc

  Processing                                                                                    Adhere to   Carried   Checked
                                                                                                SOP Nr.     out by    By
        Prepare equipment to be utilized
        Comminute the required number of A to a fine powder
        Add about 1/5 of the vehicle C to the powdered A and
         'mix to a uniform paste, add the vehicle C and D in small portions and mix
        Add sufficient E to final volume (!) and mix
        Fill portions of 50 ml of the homogenised suspension
        In bottles, add caps and seal
        Labelling and equipment cleaning

        Units filled
        Units sterilised from..................to.................o'clock
        Units defective
        Units containing visible particles
        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
                                                                                                           9/30/2012 of Outprint

  Quality control
      Sensual tests                Aspect:opaque suspension                         Odourless
                                   Taste: sweet                                     Colour: white

      Identity tests:
      1. Hydrochlorothiazide: 1drop+1dropNa2CO3 TS+1drop KmnO4 TS→violet→brown (after a few minutes)

      Physical & analytical data                         Minimum     Expected value Maximum         Measured

        PH-value (indicator paper)

      Additional tests as requested        □ Sterility               □ LAL          □ other

      Result of quality control            Result:                   Date:               Signed

  Batch record reviewed
                      Batch accepted
                               Blocked                               Date:               Signed

      References (issued: 05/2011)
      1. Monograph
      2. Formulation
      2.1 „Stability of labetalol...spironolactone with hydrochlorothiazide“ Allen LV, Erickson MA
            1996; Am.J.Health Syst.Pharm. 53(19):2304-2309
      2.2 „Hydrochlorothiazide 5mg/ml Susp.orale avec sucre“ Formule CHUV Lausanne, Switzerld (in french)
        download: http://files.chuv.ch/internet-docs/pha/medicaments/pha_prep_ped_hydrochlorothiazidev3.pdf
        Data communicated on a poster by Griffiths W et al.at the Eur.Symp.Clin.Pharmacy, Basle, 2000
      3. Quality Control
       3.1 WHO Basic Tests for Pharm. Dosage Forms, 1991, pg 95 (§ 9.5)
       3.2 Assay: see Nr. 4.2 below
      4. Stability
         4.1 see Nr. 2.1 and 2.2 above
         4.2 „Kindgerechte Arzneizubereitungen mit diuretischen Wirkstoffen“ (Ref. 31)
          Barnscheid,L. Diss Heinrich-Heine-Uni Düsseldorf, Düsseldorf (2008) (in German)
          Stability: pg. 57-58
          HPLC method: pg. 108-118
      5. Essential Medicines 17th ed. WHO Model List (March 2011)
         12.4 Medicines used in heart failure. Hydrochlorothiazide, Oral Liquid 50mg/5ml (!)
      6.1 Other Monographs
      6.2 Other Formulations
         „Hydrochlorothiazide Oral Suspension 5mg/ml“ Nationwide Childrens Hospital, Columbus OH, USA
            download: www.nationwidechildrens.org/outpatient-pharmacy-services

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

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