Page 7 - Extemp Marking Scheme
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FAR 222/3 Dosage Form II                    Extemporaneous Exercise – Marking Scheme 2019 – 2020


               Exercise 3.5 A

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

                NAME:                                                       DATE:
                ADDRESS:                                                    AGE:          SEX:

                         Mephentermine IM 100 mg stat. – Dose change to 50 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
                                Mephentermine sulphate                  0.84 g    1M
                                                                        20 mL
                                                                        (Stock
                                     Chlorocresol                                 1M
                                                                         0.2
                                                                        %w/v)
                                                                        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          Autoclave                 Aseptic filtration
                 STERILISATION       Duration              15 min                         -
                   -3M (1M ea)      Condition                                    Laminar flow hood -1M
                                   (temperature,     121-123°C, 1.05 kgf/cm    Swinnex filter holder with a 0.22 µm
                                                                      2
                                   pressure etc)                                  membrane filter -1M

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