The Tablet Hardness Test measures the resistance of tablets to breaking or cracking.
Test Objective:
To determine the hardness (crushing strength) of tablets.
Test Apparatus:
1. Tablet Hardness Tester (e.g., Monsanto, Dr. Schleuniger)
2. Compression Gauge
Test Procedure:
1. Prepare tablets for testing.
2. Place tablet between jaws of hardness tester.
3. Apply gradual pressure until tablet breaks.
4. Record hardness value (in kg, N, or lb).
Acceptance Criteria:
1. Minimum hardness: 4-6 kg (USP)
2. Range: 4-12 kg (Ph. Eur.)
Factors Affecting Hardness:
1. Compression force
2. Tablet thickness
3. Excipient properties
4. Moisture content
5. Storage conditions
Regulatory Guidelines:
1. USP <724> “Tablet Hardness”
2. Ph. Eur. 2.9.8 “Resistance to Crushing of Tablets”
3. ICH Q6A “Specifications: Test Procedures and Acceptance Criteria”
Importance:
1. Ensures tablet stability during handling and storage.
2. Affects tablet friability and disintegration.
3. Impacts patient compliance.
Troubleshooting:
1. Low hardness: adjust compression force or formulation.
2. High hardness: may indicate over-compression.
Common Hardness Testers:
1. Monsanto Hardness Tester
2. Dr. Schleuniger Hardness Tester
3. Metrohm Hardness Tester
Alternative Methods:
1. Compression Testing
2. Tensile Strength Testing
By conducting the Tablet Hardness Test, manufacturers ensure tablets meet quality standards.
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