Nitrosamine Drug Substance-Related Impurities (NDSRIs) in Pharmaceuticals: Formation, Mitigation Strategies, and Emphasis on Mutagenicity Risks.
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| Title: | Nitrosamine Drug Substance-Related Impurities (NDSRIs) in Pharmaceuticals: Formation, Mitigation Strategies, and Emphasis on Mutagenicity Risks. |
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| Authors: | Aishwarya D; Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER)-Hajipur, Bihar, 844102, India., Ramakant Dhampalwar V; Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER)-Hajipur, Bihar, 844102, India., Pallaprolu N; Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER)-Hajipur, Bihar, 844102, India., Peraman R; Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER)-Hajipur, Bihar, 844102, India. drram@niperhajipur.ac.in. |
| Source: | Pharmaceutical research [Pharm Res] 2025 Apr; Vol. 42 (4), pp. 547-578. Date of Electronic Publication: 2025 Apr 23. |
| Publication Type: | Journal Article; Review |
| Journal Info: | Publisher: Kluwer Academic/Plenum Publishers Country of Publication: United States NLM ID: 8406521 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-904X (Electronic) Linking ISSN: 07248741 NLM ISO Abbreviation: Pharm Res Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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| ISSN: | 1573-904X |
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| DOI: | 10.1007/s11095-025-03857-9 |
