Table 3.

Assays from European Pharmacopoeia for quality and assurance control

Analysis	Method of reference	Acceptance criteria
General aspect	Visual	Posological unit integrity
Uniformity of content	Assay 2.9.6	Each individual content is between 85% and 115% of the average content (10 dosage units)
Uniformity of mass	Assay 2.9.5	Not more than two of the individual masses deviate from the average mass by more than ±10% and none deviates by more than ±20% (20 dosage units)
Disintegration	Assay 2.9.1	At the end of the specified time all of the dosage units must have disintegrated completely
Friability	Assay 2.9.7	Maximum loss of mass not more than 1%
Hardness	Assay 2.9.8	Hardness between 4 and 10 N