A former US Food and Drug Administration (FDA) official said the agency’s draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to ...

The key market opportunities lie in providing training for analytical method validation, focusing on drug substance and product analysis. This includes lab procedure transfer techniques, compendial ...

It also addresses limitations of the current method and explores strategies to improve its robustness and reliability, leveraging the capabilities of the Fourier 80. With its compact, cryogen-free ...

Subvisible particulate matter is under increasing amounts of scrutiny in the field of parenteral and ophthalmic drug products. USP <1788> and <1788.3> explicitly recommend the use of flow imaging and ...