Page 9 - Extemp Marking Scheme

FAR 222/3 Dosage Form II Extemporaneous Exercise – Marking Scheme 2019 – 2020

Exercise 3.5 B

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

NAME: DATE:
ADDRESS: AGE: SEX:

Mepyramine IV 500 mg sext. hor. × 3/7 – 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
Mepyramine maleate 1 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
STERILISATION Duration 15 min
-3M (1M ea) Condition
(temperature, 121-123°C, 1.05 kgf/cm
2
pressure etc)

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