Page 59 - Dosage 1-part2 -ebook_Neat

30/10/2025, 00:02 Pharmaceutical Solutions & Sterile Dosage Forms

Quality control testing and evaluation (BP)

Tests for the whole batch

I. Leaker test (Leakage):

Test for complete sealing (no leakage) of the ampoules.

Immerse the ampoules directly after autoclaving in water bath containing methylene blue (1%).
Test the ampoules visually and reject any colored ampoules.

II. Clarity test (For visible particles):

Test the presence of visible particles › 50 μm in the injection.
The injections are tested visually by human inspection under good light against white and black
backgrounds.

Any container having visible particles is rejected. (WHY??!!)

Tests for samples of the batch

A. Sterility tests

Test presence of micro-organisms.

B. Pyrogen tests

1. Rabbit pyrogen test
2. Bacterial endotoxin test (LAL test)

C. Extractable volume test:

Measured the volume that can be extracted from the container.
It should not be lower than the labeled volume.

D. Clarity test for sub-visible particles

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