In-house harmonization of excipient specifications ensures compliance with multiple pharmacopoeias, reducing redundant testing and aligning with global regulatory expectations. Specification ...
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 ...
Elemental impurity risk management can help biomanufacturers to maintain regulatory alignment and ensure patient safety.
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 ...
WILMINGTON, N.C., March 30, 2011 /PRNewswire/ -- AAIPharma Services Corp., a leading provider of pharmaceutical product development and manufacturing services, has relocated its compendial raw ...
The new <1226>, 'Verification of Compendial methods' was published in second supplement to USP 30 - NF 25 (2007) and is now official. Compliance to USP <1226> is one of the FDA requirements for ...
Natural cyclodextrins (CDs) and their synthetically modified forms, hydroxypropyl-β-cyclodextrin (HP-β-CD) and sulfobutyl-β-cyclodextrin (SB-β-CD), are critical components in pharmaceutical ...
Dublin, Feb. 27, 2025 (GLOBE NEWSWIRE) -- The "3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA/EMA, USP and ICH" training has been ...
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