Apr 2, 2009 ... The US Food and Drug Administration defines a reference-standard material as a "highly purified compound that is well characterized" (1).
May 5, 2017 ... In API manufacturing, reference standards can help ensure identity, ... to determine assay performance or impurity method qualification.
Mar 1, 2014 ... He described their course of development of requirements with respect to qualification, filing, and monitoring of a reference standard.
A.6 Handling and distribution of chemical reference substances. A.6.1 Packaging ... other laboratories. However, in principle, secondary reference standards.
Our RSM qualification programs can be applied to reference standards used for assay, impurity or degradation product quantification, metabolite quantification ...
Storage, Usage, Disposal of Reference Standards and Qualification, Numbering, Packing, Storage, Usage and Disposal of Working Standards.
The objective of this commentary is to provide our opinions on the best practices for reference standards and key reagents, such as metabolites and internal ...
Reference standards play a critical role in pharmaceutical drug development from ... Primary standard qualification requires extensive characteriza- tion and ...
Feb 8, 2012 ... Members of USP Council of Experts and USP Reference Standards Committee .... Qualification of one national primary reference material by ...
Get answers to frequently asked questions about USP's Reference Standards.