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.
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Vaganova et al. (2024) studied this question.
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