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 |
| _version_ | 1797199025159536640 |
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| author | O. A. Matveeva |
| author_facet | O. A. Matveeva |
| author_sort | O. A. Matveeva |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-07T19:17:36Z |
| format | Article |
| id | doaj.art-eac0d3299ecf4202b4165d98270f65a0 |
| institution | Directory Open Access Journal |
| issn | 1991-2919 2619-1172 |
| language | Russian |
| last_indexed | 2024-04-24T07:09:11Z |
| publishDate | 2022-10-01 |
| publisher | NEICON ISP LLC |
| record_format | Article |
| series | Ведомости Научного центра экспертизы средств медицинского применения |
| spelling | doaj.art-eac0d3299ecf4202b4165d98270f65a02024-04-21T11:46:35ZrusNEICON ISP LLCВедомости Научного центра экспертизы средств медицинского применения1991-29192619-11722022-10-0112324124310.30895/1991-2919-2022-12-3-241-243350Control of Residual Organic Solvents in Active SubstancesO. A. Matveeva0Scientific Centre for Expert Evaluation of Medicinal ProductsDepending 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.https://www.vedomostincesmp.ru/jour/article/view/497active substanceorganic solventspermissible daily exposureproduct specification filespecification |
| spellingShingle | O. A. Matveeva Control of Residual Organic Solvents in Active Substances Ведомости Научного центра экспертизы средств медицинского применения active substance organic solvents permissible daily exposure product specification file specification |
| title | Control of Residual Organic Solvents in Active Substances |
| title_full | Control of Residual Organic Solvents in Active Substances |
| title_fullStr | Control of Residual Organic Solvents in Active Substances |
| title_full_unstemmed | Control of Residual Organic Solvents in Active Substances |
| title_short | Control of Residual Organic Solvents in Active Substances |
| title_sort | control of residual organic solvents in active substances |
| topic | active substance organic solvents permissible daily exposure product specification file specification |
| url | https://www.vedomostincesmp.ru/jour/article/view/497 |
| work_keys_str_mv | AT oamatveeva controlofresidualorganicsolventsinactivesubstances |