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

Backup slides with definitions. 8. Establishment of a chemical Reference. Standard (assay active substance). • Primary reference standard. – Selected batch with ...

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

Feb 8, 2012 ... Qualification of a national primary reference material to support a ... VIM also defines reference standards (see “Definitions”), and there is little ...

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

Apr 2, 2009 ... The author reviews the types of reference-standard materials used in drug- product manufacturing, discusses current ... Compendial (primary):.

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 ... 11 18 Where a primary reference standard is not available from an officially. • 11.18 Where a .... must be defined ” must be defined.

https://www.itl.nist.gov/div898/handbook/mpc/section3/mpc312.htm

Primary reference standards, A reference standard for a unit of measurement is an artifact ... Mass is the only unit of measurement that is defined by an artifact.

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

May 5, 2017 ... Reference standards can be compendial, referred to as Primary Reference Standard, or a highly characterized in-house standard or a ...

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

Convenient and cost-effective alternative to primary reference standards, with traceability to USP, BP, EP standards; manufactured to ISO/IEC 17025 and ISO ...

https://hmc.usp.org/sites/default/files/documents/HMC/GCs-Pdfs/c11.pdf

Official USP RS are primary standards in jurisdic- ... USP RS are Reference Materials as defined in the International Vocabulary of Metrology—Basic and.

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 ...

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

Mar 1, 2014 ... Official Reference Standard: According to ICH Q7 definition, it is a primary reference standard obtained from an “officially-recognized source.