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, potency, ... by analyzing the substance against its qualified reference standard, ... and Drug Administration (FDA) defines a reference-standard material as a ...

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

Mar 1, 2014 ... Sarah Kennett of FDA's Center for Drug Evaluation and Research (CDER) .... In addition, the postapproval reference standard qualification ...

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/analytical-procedures-and-methods-validation-drugs-and-biologics

Submit comments on this guidance document electronically via docket ID: FDA- 2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets ...

https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073488.pdf

Aug 18, 1999 ... have been compared with an appropriate reference standard, if available. ... against an international or national reference standard, when ...

http://www.fda.gov/files/drugs/published/Guideline-for-Submitting-Supporting-Documentation-in-Drug-Applications-for-the-Manufacture-of-Drug-Substances.pdf

qualify each new source/supplier of the new starting material should be ... reference standard substance used, including the description of the purification steps.

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

This commentary will focus on reference standards and key reagents, such as ... have either been revised (10,11) or are in the process of revision (FDA). ... they are often in limited supply and only distributed to qualified laboratories (20).

https://www.slideshare.net/bhavanavedantam/reference-standards-in-pharmaceutical-industries

Jan 28, 2014 ... This presentation is brief introduction about reference standards that are using ... Other Definitions: FDA: Specifically prepared drug substance batch and an .... Characterization Of Reference Standards Qualification of RSs is a ...

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

Feb 8, 2012 ... Qualification of one national primary reference material by .... FDA adds that a working standard must be qualified against a primary reference ...

https://en.wikipedia.org/wiki/Drug_reference_standard

A drug reference standard is a standardized substance which is used as a measurement base for similar substances. Where the exact active substances of a ...