: For identification and patient compliance. Key Quality Control Tests
The mandatory test for this assessment is as follows: take 30 tablets at random, break them by hand, and from each tablet, select one part for testing, discarding the other(s). Weigh each of the 30 parts individually and calculate the average mass. The tablets comply if no more than one individual mass falls outside the range of 85% to 115% of the average mass. This procedure is not a routine batch release test but must be performed during product development or for validation purposes.
| 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 . | European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
While it primarily covers standard oral tablets, the monograph explicitly segmentizes several distinct categories of tablets, each with tailored criteria:
Ph. Eur. 0478 allows a "re-test" for disintegration (repeat on 6 new tablets) if 1-2 of the first 6 fail. USP <701> requires that if 1-2 fail, you test 12 more; if more than 2 fail initially, rejection is immediate. : For identification and patient compliance
: Delayed-release formulations designed to resist gastric fluid breakdown and release the active drug inside the intestinal fluid. They are typically coated with acid-resistant polymers.
Revised in Supplement 9.3, this requires that break-marks be functional. If used for fractional dosing, the subdivided parts must meet strict uniformity of mass standards (e.g., 30 parts tested; most must be within 85–115% of average mass). The tablets comply if no more than one
The majority of Monograph 0478 is dedicated to mandatory physical tests. Failure in any of these three categories results in batch rejection.
