Page 18 - FAR 222 Laboratory Manual V2 2019

FAR 222/3 Dosage Form II Semester 1/ 2019-2020

Exercise 2.2
Ethanolamine IV 1 mL at different sites of lower right limb q. 7 d. × 3/12

Questions :
1. What is a sclerosing agent?
2. How do you ensure the final injection solution is clear?

Ethanolamine oleat injection BPC (page 713)
Density 50 mL
1.014-1.023 Ethanolamine 0.91 g 0.46 g (0.45 mL)
0.889-0.895 Oleic acid 4.23 g 2.12 g (2.38 mL)
Benzyl alcohol 2 mL 1 mL
Water for injection 100 mL 50 mL
2. What measure must be taken to ensure the injection is clear?
Do not add oleic acid in excess because Oleic acid is not miscible with water.

Method:
1. See BPC page 731 – Tare a clear bottle (100 mL)
2. Filter solution with a separate set of filter
3. Volume injection in each ampoule:
Volume Vehicle Overage Total Volume
1 mL Water 0.1 mL 1 + 0.1 = 1.1 mL
4. Transfer 1.1 mL solution into each ampoule using syringe.
5. Seal the ampoules
6. Conduct a leakage test and sterilisation simultaneously.
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7. Sterilise the preparation by autoclaving at temp 121 - 123°C, pressure 1.05 kgf/cm and
time 15 min.
8. Label the preparation

Label:
Ampoule
ETHANOLAMINE OLEATE INJECTION BPC
5 %w/v
Intravenous injection
Date of sterilisation:
Expiry date:
BN:

Box
10 x 1 mL ampoules
ETHANOLAMINE OLEATE INJECTION BPC
5 %w/v
Bactericide: Benzyl alcohol 2 %v/v
To be used for intravenous injection only as sclerosing agent
Protect from light
Store at room temperature
Date of sterilisation:
Expiry date: 2 years
BN:
Name of patient: Date of dispensing:
Keep out of Reach of Children

SCHOOL OF PHARMACEUTICAL SCIENCES,
USM, PENANG

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