http://www.pharmtech.com/reference-standard-material-qualification

Apr 2, 2009 ... The US Food and Drug Administration defines a reference-standard material as a "highly purified compound that is well characterized" (1).

https://www.pcisynthesis.com/reference-standards-in-api-drug-development-manufacturing/

May 5, 2017 ... In API manufacturing, reference standards can help ensure identity, ... to determine assay performance or impurity method qualification.

https://bioprocessintl.com/upstream-processing/assays/reference-standards-for-therapeutic-proteins-350518/

Mar 1, 2014 ... He described their course of development of requirements with respect to qualification, filing, and monitoring of a reference standard.

http://apps.who.int/medicinedocs/documents/s21438en/s21438en.pdf

A.6 Handling and distribution of chemical reference substances. A.6.1 Packaging ... other laboratories. However, in principle, secondary reference standards.

http://www.intertek.com/pharmaceutical/analysis/reference-standards/

Our RSM qualification programs can be applied to reference standards used for assay, impurity or degradation product quantification, metabolite quantification ...

https://www.pharmaguideline.com/2011/07/guidelines-for-receipt-and-usage-of.html

Storage, Usage, Disposal of Reference Standards and Qualification, Numbering, Packing, Storage, Usage and Disposal of Working Standards.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3933579/

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 ...

https://www.eag.com/fr/wp-content/uploads/2017/12/M-029817-ABCs-of-Reference-Standards-FINAL.pdf

Reference standards play a critical role in pharmaceutical drug development from ... Primary standard qualification requires extensive characteriza- tion and ...

https://link.springer.com/article/10.1007/s11095-012-0687-7

Feb 8, 2012 ... Members of USP Council of Experts and USP Reference Standards Committee .... Qualification of one national primary reference material by ...

https://www.usp.org/frequently-asked-questions/reference-standards

Get answers to frequently asked questions about USP's Reference Standards.