Recommendations for the Contents of a Product Specification File: Related Substances (HPLC)
https://doi.org/10.30895/1991-2919-2023-13-3-473-480
Abstract
This article provides recommendations for documenting an analytical procedure for the determination of related substances by high-performance liquid chromatography in a product specification file (PSF). The article contains a description of specific aspects and a template for the typical contents and layout of the PSF section dedicated to related substances. A unified approach to the PSF content and layout will ensure error-free testing, reliable results, and streamlined regulatory assessments.
About the Authors
O. A. Vaganova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
Olga A. Vaganova, Cand. Sci. (Pharm.)
8/2 Petrovsky Blvd, Moscow 127051
A. A. Natykan
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
Alexey A. Natykan, Cand. Sci. (Chem.)
8/2 Petrovsky Blvd, Moscow 127051
Supplementary files
|
1. Sample Template for the Product Specification File Section on Related Substances (HPLC) | |
| Subject | ||
| Type | Исследовательские инструменты | |
Download
(1MB)
|
Indexing metadata ▾ | |
Review
For citations:
Vaganova O.A., Natykan A.A. Recommendations for the Contents of a Product Specification File: Related Substances (HPLC). Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation. 2023;13(3):473-480. (In Russ.) https://doi.org/10.30895/1991-2919-2023-13-3-473-480
Views:
1090
Email this article 