Liquid Chromatographic Peak Purity Assessments in Forced Degradation Studies: An Industry Perspective-Reference-Cited by-同舟云学术

Liquid Chromatographic Peak Purity Assessments in Forced Degradation Studies: An Industry Perspective

Published:2024-01-01 Issue: Volume: Page:22-31
ISSN:2996-9077
Container-title:LCGC International
language:en
Short-container-title:LCGC Int.

Author:

Marillier Pascal¹,Adams Neal¹,Baertschi Steven W.²,Campbell John M.³,Foti Chris⁴,Franca Juçara Ribeiro⁵,Hicks Simon³,Kotoni Dorina⁶,Laue Christian⁷,Marden Stacey⁸,Meng Liping⁴,de Oliveira Santos Ana Claudia⁹,Ultramari Mariah¹⁰,Van Cleempoe An¹¹,Wang Chloe¹²,Zelesky Todd¹³,Huang Zongyun¹⁴

Affiliation:

1. Pfizer Inc

2. Baertschi Consulting LLC

3. GlaxoSmithKline

4. Gilead Sciences Inc.

5. Brazilian Health Regulatory Agency (ANVISA)

6. Novartis Pharma AG

7. Merck Healthcare KGaA

8. AstraZeneca

9. Merck Brazil

10. Spektra Soluções Científico-Regulatórias Ltd

11. Johnson & Johnson

12. Jazz Pharmaceutical

13. Pfizer Inc.

14. Bristol-Myers Squibb Co.

Abstract

This review article discusses scientific rationales and current best practices in the pharmaceutical industry for performing chromatographic peak purity assessments (PPA). These activities are associated with the development and validation of liquid chromatographic (LC) stability-indicating analytical methods applicable to regulatory submissions of small-molecule drug candidates. The discussion includes a comprehensive overview of the PPA-related regulatory and scientific landscape and common industry approaches to obtain PPA results, as well as the strengths and weaknesses of PDA-facilitated ultraviolet (UV) PPA and other PPA techniques.

Publisher

Multimedia Pharma Sciences, LLC

Reference24 articles.

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2. Reynolds, D. W.; Facchine, K. L.; Mullaney, J. F.; Alsante, K. M.; Hatajik, T. D.; Motto, M. G. Available Guidance and Best Practices for Conducting Forced Degradation Studies. Pharm Technol. 2002, 26, 48–56.

3. Aubry, A.- F.; Tattersall, P.; Ruan, J. “Development of Stability Indicating Methods." In: Huynh-Ba. K., ed., Handbook of Stability Testing in Pharmaceutical Development; Springer, 2009; 139–161.

4. Campbell, J. M.; Foti, C.; Wang, C.; et al. Assessing the Relevance of Solution Phase Stress Testing of Solid Dosage Form Drug Products: A Cross-Industry Benchmarking Study. J. Pharm. Sci. 2022, 111, 298–305. DOI: 10.1016/j.xphs.2021.06.012

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