Page 11 - Extemp Marking Scheme
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FAR 222/3 Dosage Form II                    Extemporaneous Exercise – Marking Scheme 2019 – 2020


               Exercise 2.5 C

                                       SCHOOL OF PHARMACEUTICAL SCIENCES
                                              UNIVERSITI SAINS MALAYSIA
                                                11800 USM, PENANG, MALAYSIA
                                               Tel: 04-6532211   Fax: 04-6570017

                NAME:                                                       DATE:
                ADDRESS:                                                    AGE:          SEX:

                         Metaraminol IV 50 mg b.d. × 4/7 – Dose change to 5 mg – 1M
                                                                                                     G.Eiffel
                                                                                                   G. Eiffel MD


               Question:
                   1.  Complete a pharmaceutical production document for this formulation as a multidose injection
                      and prepare the formulation accordingly. (30 marks)










                 NAME OF                                       BATCH
                 PRODUCT                                         NO.                  DATE
                                                                                  TARE   MEASURED   CHECKED
                                                                        QUANTITY
                                     FORMULA – 3M                        USED   CHECKED    BY        BY
                                                                                   BY
                                  Metaraminol tartrate                  0.76 g    1M
                                                                        20 mL
                                                                        (Stock
                                     Chlorocresol                                 1M
                                                                         0.2
                                                                        %w/v)
                              Sodium metabisulphite (0.1%)              0.03 g*   1M
                                                                        qs ad
                                   Water for injection                            1M
                                                                        40 mL








                                       Size              20 mL
                 CONTAINER -3M         Type          Multidose glass vial   FILTRATION  Sintered glass filter Grade
                     (1M ea)                      Rubber closure and metal   -1M        3 (15 – 40 µm)
                                   Closure type           cap
                                  Equipment used                       Aseptic filtration
                 STERILISATION       Duration                                -
                   -3M (1M ea)      Condition
                                   (temperature,                    Laminar flow hood -1M
                                   pressure etc)       Swinnex filter holder with a 0.22 µm membrane filter -1M

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