Page 37 - Pharmaceutics III_ 02-06-01304_Fall 2025_ Pharm D_Electronic book

Acceptable limit: ≤1%
Causes of high friability:

• Insufficient binder
• Low compression force
• Overdrying of granules

Disintegration Test:
Purpose: to measure the time required for tablets to break down into particles under specified
conditions.
Apparatus: Six-tube basket rack assembly moving vertically in 900 mL water at 37°C ± 2°C at 30
cycles/min.
Limits:

• Uncoated tablets: ≤15 min
• Film-coated tablets: ≤30 min
• Sugar-coated tablets: ≤60 min
• Enteric-coated tablets: should not disintegrate in 0.1 N HCl for 2 hours, but must

disintegrate in phosphate buffer pH 6.8 within 60 min.

Dissolution Test:
Purpose: to measure the rate and extent of drug release from tablets.
Apparatus:

1. Basket type (USP Apparatus I) – suitable for capsules and floating dosage forms.
2. Paddle type (USP Apparatus II) – suitable for most tablets.
Test conditions:
• Volume: 900 mL
• Temperature: 37°C ± 0.5°C
• Stirring speed: 50–100 rpm
Acceptance criteria (as per BP/USP):
Not less than 80% of the labeled amount of drug should be dissolved within 30 or 45 minutes.

Content Uniformity Test:
Twenty tablets are assayed individually. Each should contain 85–115% of the labeled amount
and RSD ≤ 6%.

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