Module 3 - Strategic case studies in practice

COLD RELIEF CAPSULES/GRANULES

METHOD OF TEST

SAMPLING

Take a random sample form the batch of about 300 capsules or 50 g granules. Spread the capsules on a flat surface and examine for general appearance. Open several capsules and examine the contents. Weigh individually 20 filled capsules, empty them out and weigh the shell. Record the individual weights. Find the average fill weight. Check that the samples are within the criteria of the specification. Place 1 capsule in each of the tubes of the standard apparatus and determine the time in minutes for each of the capsule contents to pass through the mesh, using water at 37·c. Compare the retention times of component peaks in the chromatograms of the assay procedures with standards. They should be within 5% of each other. Compare with a previous sample.

APPEARANCE

UNIFORMITY OF WEIGHT/ AVERAGE NET WEIGHT

DISINTEGRATION OF CAPSULES

IDENTITIES

0