Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the ...
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 ...
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 ...
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 ...
The Online Services portal gives customers of AAIPharma Services the flexibility to select the pharmacopeia, material and tests from a database; enter the number of preparations, special instructions ...
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 ...
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 ...
Metronidazole in aqueous solution is sensitive to light and UV irradiation, leading to the formation of N-(2-hydroxyethyl)-5-methyl-l,2,4-oxadiazole-3-carboxamide. This is revealed here by liquid ...
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