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o ≤80 mg → ±10%
o 80–250 mg → ±7.5%
o ≥250 mg → ±5%
3. Weight variation: 20 tablets weighed individually.
4. Content uniformity: each tablet assayed; must be 85–115% of label claim.
5. Thickness: ±5% variation allowed.
6. Hardness (crushing strength): 4–8 kg for conventional tablets.
7. Friability: ≤1% weight loss (tested using Roche friabilator).
8. Disintegration:
o Uncoated: ≤15 min
o Coated: ≤30 min
9. Dissolution: at least 80% drug release within 30–45 min.
Tablet Hardness Test:
Purpose: to determine the ability of a tablet to resist breaking under conditions of handling,
packaging, and transportation.
Instruments:
• Monsanto hardness tester
• Pfizer hardness tester
• Schleuniger tester
Acceptable range: 4–8 kg/cm² for conventional tablets.
Factors affecting hardness:
1. Compression force
2. Binder concentration
3. Moisture content
4. Granule size and porosity
Friability Test:
Purpose: to determine tablet ability to resist abrasion.
Instrument: Roche friabilator.
Tablets are rotated 100 times at 25 rpm; dedusted and reweighed.
Calculation:
% Friability = (Initial wt – Final wt) / Initial wt × 100
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