The authors describe a modified version of the Large-N test used to determine content uniformity. Applications of process analytical technology (PAT) for in-process and/or end-product release testing ...

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, ...

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 ...

Review challenges in the use of normality testing situations and recommendations on how to assess data distributions in the pharmaceutical development manufacturing environment Statisticians ...

For example, the letter said Mylan failed to complete a content uniformity test--a USP requirement--after loperamide hydrochloride capsules flunked conformance testing. In addition, in responding to ...