M1L15 - Quality control

API content test

This involves 20 tablets chosen at random, powdering and assaying them. Limits are decided by a pharmacopeial monograph (usually permit ±10%)

Content uniformity test

This involves 10 tablets assayed individually for API content, with limits decided by a pharmacopeia (often ±15% of stated concentration)

Weight uniformity test

This involves 20 tablets individually weighed. 2 tablets permitted over 10% stated if <80mg; 2 tablets permitted over 7.5% stated if 80-250mg; 2 tablets permitted over 5% stated it >250mg. 1 permitted to deviate from twice the limit

Disintegration test

This involves 6 tablets agitated in a water bath. Uncoated in 15 min; soluble in 3 min; coated in 30-60 min; enteric-coated >2h in 0.1 M HCl

Dissolution test

This tests the speed at which the tablet dissolves into solution

Friability test

This tests a tablets’ resistance to abrasion. Subject to uniform tumbling for a specified time and weight loss is measured

Hardness test

This tests the force required to break a tablet, should be between 50-80 N