Comprehensive Identification Tests:
Rigorous Uniformity Testing:
Dissolution & Disintegration – The Core QC: European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
Cross-Referencing System:
Storage & Packaging Clauses:
These are standard uncoated or coated tablets intended to release the active substance rapidly in the gastrointestinal tract.
Tablets are solid preparations each containing a single dose of one or more active substances. They are obtained by compressing uniform volumes of particles or by another suitable manufacturing process (e.g., compaction, granulation followed by compression). Comprehensive Identification Tests:
These have separate monographs (e.g., 2066, 2067, etc.).
The active substance(s) must be identified using the tests prescribed in the specific monograph for that substance (e.g., spectroscopy, chromatography). Rigorous Uniformity Testing: