Recommendations for the Content of a Product Specification File: Water (Karl Fischer Method)
https://doi.org/10.30895/1991-2919-2024-14-3-370-372
Abstract
This article provides recommendations for documenting an analytical procedure for water determination by Karl Fischer titration in a product specification file (PSF). The article contains a description of specific aspects associated with the test and a template for the typical content and layout of the corresponding PSF section. 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
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1. Sample Template for the Product Specification File Section on Water Determination (K. Fischer Method) | |
| Subject | ||
| Type | Исследовательские инструменты | |
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For citations:
Vaganova O.A., Natykan A.A. Recommendations for the Content of a Product Specification File: Water (Karl Fischer Method). Regulatory Research and Medicine Evaluation. 2024;14(3):370-372. (In Russ.) https://doi.org/10.30895/1991-2919-2024-14-3-370-372
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