Control of Residual Organic Solvents in Active Substances

Autor:	O. A. Matveeva
Jazyk:	ruština
Rok vydání:	2022
Předmět:	active substance organic solvents permissible daily exposure product specification file specification Medicine (General) R5-920
Zdroj:	Регуляторные исследования и экспертиза лекарственных средств, Vol 12, Iss 3, Pp 241-243 (2022)
Druh dokumentu:	article
ISSN:	3034-3062 3034-3453 1991-2919
DOI:	10.30895/1991-2919-2022-12-3-241-243
Popis:	Depending on the class of toxicity, organic solvents used or formed during the production of active substances may pose risks to human health. Therefore, residual Depending on the class of toxicity, organic solvents used or formed during the proorganic solvents must be controlled, and limits for their content must be established. The article covers requirements and approaches to the assessment and establishment of maximum permissible quantities of residual organic solvents in active substances. This will help applicants decide on the need to either include the residual solvent control into product specification files or justify its absence in order to ensure the safety of medicines.
Databáze:	Directory of Open Access Journals
Externí odkaz:	https://doaj.org/article/eac0d3299ecf4202b4165d98270f65a0 Zobrazit plný text záznamu View record in DOAJ