Substantial interest has been shown towards the testing of solid dosage samples more often than the ten per batch recommendation by the US Pharmacopeia monograph on content uniformity (CU). The ...
Additionally, Content Uniformity (CU), which relies heavily on the proper blend uniformity of the final pharmaceutical product, must be verified for product release. During the development process, ...
Validating the match between the active ingredient content mentioned in the packaging and the actual content in each tablet in a batch is a critical step in tablet manufacture. Highly precise ...
The Process Analytical Technology (PAT) initiative of the FDA helps pharmaceutical companies to improve the production process and consistently deliver products of better quality. For this purpose, it ...
An FDA report found that certain split tablets did not meet USPs Uniformity of Dosage Units accepted criteria. The Food and Drug Administration (FDA) have reported that split tablets from amlodipine ...