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Vaganova, O. A.; Natykan, A. A.
Vedomosti Naučnogo centra èkspertizy sredstv medicinskogo primeneniâ (Online), 09/2023, Letnik: 13, Številka: 3Journal Article
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.
