Control of Residual Organic Solvents in Active Substances
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 the...
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| Format: | Article |
| Language: | Russian |
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NEICON ISP LLC
2022-10-01
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| Series: | Ведомости Научного центра экспертизы средств медицинского применения |
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| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/497 |
| Summary: | 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. |
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| ISSN: | 1991-2919 2619-1172 |