Ephedrine 1pc 2ml

							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.                                                                      EPHEDRINE Injection 10 mg/ml
   Date planned 17/07/11                                   Product name/Conc.       Hydrochloride 20mg = 2 ml Vial
   Date started                                            Total quant./Vol./Form      (1%)         (50 micromol/ml)
   Batch size           200 ML                                                         Without conserving agent
   Batch quantity       100 Items of                  2 ML                             For single use only
   Density          1.0050                                                             Protect from light
   Shelf life            12 Months                                      Expiry Date                 Exp.Date 17/07/12

  Composition                                                   Factor:          1.0000                Weighed Checked
  Ingredients          Prod.Check by N.N.                                    Quantity       Lot Number By N.N. By N.N.
   A 50-98-6                    Ephedrine hydrochloride *)                          2.00 GM            *
   B 7647-14-52                 Sodium chloride parent.use                          1.20 GM
   C 7732-18-5-2                Water for injections                             197.80 GM

     *) Ephedrine sulfate (CAS 134-72-5) may be used
       In a 5% higher amount
  Sum of ingredients                                                              201.00 GM

  Materials
                       Mat.Check by N.N.                                                         Lot Number Checked by N.N.
   O          63444             Filter round 1.2µ 47mmØ                                 1   Pc
   P.         63720             Vials white glass Type I 2ml                          100   Pc
   Q          64386             Rubber stoppers red 12mm                              100   Pc
   R          62871             Aluminiumcaps 13mm silver                             100   Pc
   S          63010             Labels white 30x15mm                                  105   Pc

  Processing                                                                                     Adhere to   Carried   Checked
                                                                                                 SOP Nr.     out by    By
        Prepare equipment to be utilized
        Dissolve A and B in C and filtrate across membrane filter
        Fill portions of 2.2ml under Laminar Air Flow, add stoppers, caps & seal
        Sterilisation: 120º C / 20 min, Equipment cleaning and labelling

        Alternative processing:
        Fill the filtrated solution into infusion bottle(s) and sterilise 120°C/20min
        Aseptically (under LAF) fill 2.0ml into sterile syringes, add sterile
        Stoppers and place in suitable containers

        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. 1
                                                                                                          8/8/2012 of Outprint




  Quality control
      Sensual tests                Aspect: clear solution                            Odourless
                                   Taste: bitter                                     Colourless

      Identity tests:
       1. Ephedrine: 1drop+1 drop CuSO4TS+1drop nNaOH→violet colour
       2. Sodium: Yellow colour of flame
       3. Chloride: 1drop+1drop dil.HNO3+1drop AgNO3→white precipitate

      Physical & analytical data                          Minimum Expected Value Maximum Measured
       Refractive index                                       1.3355  1.3360         1.3365
       pH-value                                                   4.5      5.5           7.0
       E 257nm (5:100ml) Ephedrine                             0.430    0.480         0.530

      Additional tests as requested         □ Sterility               □ LAL          □ other

      Result of quality control             Result:                   Date:               Signed




  Batch record reviewed
                      Batch accepted
                               Blocked                                Date:               Signed

       References (issued 06/2011)

       1. Monograph
          “Ephedrine Injection” BP 2011, § 9.7 Nr. 23
       2. Formulation
          “Ephédrine HCL 10mg/ml seringue 2ml”
           Protocoles Pharmacie des Hôpitaux Universit. Genève, Switzerland (07/08/2006 and 05/10/2007)
       3. Quality control
          see Nr. 2 above and Monograph „Ephedrine HCL“ Int.Ph. (Identity test A)
       4. Stability
           “The stability of ready-to-use ephedrine hydrochloride in polypropylene syringes for use in maternal
            hypotension” Griffiths W et al., Eur.J.Hosp.Pharm.Science 2005, 11(5) 107-110
            Download see § 9.7 Ref. Nr. 12
       5. Essential Medicines 17th ed. WHO Model List (March 2011)
           1.2 Local anaesthetics. Complementary list: Ephedrine Inj.:30mg(hydrochloride)/ml in 1-ml ampoule
       6.1 Other monographs
          “Ephedrine Sulfate Injection” USP 33 § 9.7 Ref.Nr. 10
       6.2 Other formulations
           -




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