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 ...

SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) announced today that the FDA has approved a content uniformity (CU) method using the Agilent TRS100 Raman quantitative ...

Traditional formulations commonly struggle to achieve content uniformity with morphologically challenging active pharmaceutical ingredients (APIs), requiring the use of complicated processes such as ...

Standardized methods are needed for the preparation of pediatric medicines, indicates a doctoral dissertation. Hospital pharmacies modify adult medicines for children when there are no suitable ...

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 ...

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 ...