Page 36 - Pharmaceutics III_ 02-06-01304_Fall 2025_ Pharm D_Electronic book
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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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