Products Cited in Publications Worldwide Compendial testing of antiretroviral drug reference standards for metrologic traceability: Bictegravir and cabotegravir

Compendial testing of antiretroviral drug reference standards for metrologic traceability: Bictegravir and cabotegravir

Wood, Troy D; Browne, Richard W; Tiede, Erin R; Gould, Connor E; Ghazal, Diala; DiFrancesco, Robin; Morse, Gene D

DOI:

Abstract

ISO/IEC 17043:2015 specifes general requirements for the competence of providers and development and operation of profciency testing schemes. As a requirement of ISO/IEC 17043:2015 accreditation, the Clinical Pharmacology Quality Assurance (CPQA) program uses ISO 17034 certifed reference materials (CRMs) to produce profciency testing materials in antiretroviral drug panels. CRMs that meet the ISO/IEC 17034 standard can be prohibitively expensive for CPQA participating laboratories (CPLs), requiring authentication of purity and identity by compendial testing. Here, to assist CPLs, we report on a compendial testing approach used to assess whether standard reference materials for and , two commonly prescribed drugs used in combination regimens in the treatment of HIV-1 infection, for profciency testing. Our approach uses high-performance liquid chromatography and thermogravimetric analysis to evaluate purity of the materials, and the combination of high-resolution mass spectrometry and proton nuclear magnetic resonance spectroscopy to establish molecular identity. Using this workfow, we identifed standard reference materials for and that are economical alternatives for CPLs.

Keywords

; ; Antiretroviral ; Profciency testing ; Quality assurance ; Metrology

Purchased from AmBeed

Cabotegravir

A1152081051375-10-098%

Cabotegravir

10.0/1mg

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