USP’s Diane McCarthy on the emerging standards platform and opportunities for stakeholders to help shape standards evolution.

For the bio/pharmaceutical industry, compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the ...

Natural cyclodextrins (CDs) and their synthetically modified derivatives, hydroxypropyl-β-cyclodextrin (HP-β-CD) and sulfobutyl-β-cyclodextrin (SB-β-CD), are widely used in pharmaceuticals as ...

A former US Food and Drug Administration (FDA) official said the agency’s draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to ...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 process of method modernization, which involves integrating advancements in system and column technology for routine analysis, is a challenge many regulated laboratories face due to a larger focus ...

Standardizing on Ph. Eur. methods generally ensures compliance with USP–NF and JP requirements, applying the tightest acceptance criteria for multi-compendial compliance. Differences in compendial ...

Compendial methods rely on Nuclear Magnetic Resonance (NMR) to meet this need. This whitepaper demonstrates how the USP-NF and Ph. Eur. NMR assay procedures for HP-β-CD and SB-β-CD can be effectively ...

WILMINGTON, N.C., Sept. 21, 2011 /PRNewswire/ — AAIPharma Services Corp., a leading provider of pharmaceutical product development and manufacturing services, has launched an online quote generation ...