Standards (Reference standards, Working standards)

USP, EP, USFDA, EDQM requirements for Pharmaceutical Reference Standards, Secondary Standards, Qualification and traceability, WHO guidelines for Chemical Reference Substances, Characterisation and Qualification of Reference standards and Reference materials

• 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