The authors discuss a new approach to address globally harmonized compendial standards. Twenty-first century challenges require 21 st century solutions. This fact applies broadly in our current global ...
Substituting a compendial-grade material with a food-grade material is not acceptable, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates. Q: I work for a 503B ...
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 ...
USP plans to release a new version of the Chapter 1226. This seminar will provide all information on existing and new USP and FDA requirements. Attendees will also receive strategies and tool kits ...
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 ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback