Standards (Reference standards, Working standards) – Qvents

Qvents

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Updated on October 20, 2023

Updated on October 20, 2023

USP Chapter 11: REFERENCE STANDARDS (Access USP)
European Pharmacopoeia Chapter 5.12 – Reference Standards (Access Ph Eur)
USFDA Guidance Analytical Procedures and Methods Validation for Drugs and Biologics Section V. REFERENCE STANDARDS AND MATERIALS
Secondary Standards – Considerations in Traceability to Pharmacopoeial Standards (USP& EDQM Joint presentation October 2023)
The Value of Pharmacopeial Reference Standards (Christian Zeine, Doug Podolsky, Jane Weitzel, Ravi Reddy, Steven L. Walfish, Pharmaceutical Technology-02-02-2021, Volume 45, Issue 2) – Useful Reference paper
Reference-Standard Material Qualification; Pharmaceutical Technology, Pharmaceutical Technology-04-02-2009, Volume 33, Issue 4
WHO TRS 943 – Annex 3: WHO general guidelines for the establishment, maintenance and distribution of chemical reference substances
Reference Standard Characterization – Steve Lane, General Manager, NSF Reference Standards
Other references: ICH Q7A, ICH Q6B

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