Content Uniformity

1.2. Content Uniformity Test For Tablets

The content uniformity test is used to ensure that every tablet contains the amount of drug substance intended with little variation among tablets within a batch. Due to increased awareness of physiological availability, the content uniformity test has been included in the monographs of all coated and uncoated tablets and all capsules intended for oral administration where the range of size of the dosage form available include 50mg or smaller sizes. Tablet monographs with a content uniformity requirement do not have weight variation requirements ⁴ . For content uniformity test, representative samples of 30tablets are selected and 10 are assayed individually. At least 9must assay within ±15% of the declared potency and none may exceed ±25% ³ .