European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478- _top_
The monograph subdivides tablets into specific categories, each with tailored testing criteria:
Mandatory for most solid dosage forms to confirm the active substance is released as intended. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
| Test Category | Key Tests and Requirements | | :--- | :--- | | | A test to confirm the identity of the active substance(s) in the tablet, usually by a technique like chromatography or spectroscopy. | | Dissolution/Disintegration | For rapidly dissolving products, a disintegration test may suffice; otherwise, a dissolution test is required. Unless otherwise justified, a suitable dissolution test, such as one described in Ph. Eur. general chapter 2.9.3 , must be carried out. | | Uniformity of Dosage Units | This ensures the dosage form contains the correct amount of drug substance. The harmonised chapter 2.9.40 is the binding requirement for intact tablets, while monograph 0478 provides additional rules for scored tablets. | | Friability | This test (Chapter 2.9.7 ) measures the tendency of tablets to chip or break during handling and transport. | | Resistance to Crushing | This test (Chapter 2.9.8 ) measures the mechanical strength of tablets, ensuring they are hard enough to withstand processing but not too hard to prevent disintegration. | | Microbiological Quality | Tablets must comply with the limits for total microbial count and the absence of specified pathogens as per Chapter 5.1.4 . | | | Uniformity of Dosage Units | This
This monograph does not apply to lozenges, oral pastes, or oral gums, which are covered under other sections like Oromucosal Preparations (1807) . Primary Tablet Categories Primary Tablet Categories