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

Apr 2, 2009 ... Reference standards can be compendial or noncompendial and are typically obtained from the following sources. Compendial (primary):.

https://www.edqm.eu/sites/default/files/medias/fichiers/session_1_regulatory_aspects_part_1.pdf

Primary Reference Standard (example). • JLR (CaHbNcOd .HCl.H2O) ..... Miscellaneous Issues. • Qualification of Non-Ph. Eur. primary reference standards .

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

May 5, 2017 ... In API manufacturing, reference standards can help ensure identity, ... Resolution —used to determine assay performance or impurity method qualification. ... as Primary Reference Standard, or a highly characterized in-house ...

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

Part A. Primary chemical reference substances. A.1 Assessment of need for the establishment of chemical reference substances. A.2 Obtaining source material.

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

Mar 1, 2014 ... It should be noted that the term primary reference standard used here is distinct ... to the qualification protocol, and primary reference standards.

https://www.sigmaaldrich.com/analytical-chromatography/analytical-standards/certified-reference/pharmaceutical-secondary.html

Convenient and cost-effective alternative to primary reference standards, with ... in advance of any COA changes that may occur due to re-qualification etc.

http://www.seishin-syoji.co.jp/files/libs/51/20160418114138395.pdf

Jul 25, 2013 ... 11.17 Primary reference standards should be obtained as appropriate for the manufacture of APIs The source of each primary reference ...

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

Primary Standards: Primary reference standards should have a purity of 99.5 percent ... Primary standard qualification requires extensive characteriza- tion and ...

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.