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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.
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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  Data: <searchLink fieldCode="AU" term="%22Aishwarya+D%22">Aishwarya D</searchLink>; Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER)-Hajipur, Bihar, 844102, India.<br /><searchLink fieldCode="AU" term="%22Ramakant+Dhampalwar+V%22">Ramakant Dhampalwar V</searchLink>; Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER)-Hajipur, Bihar, 844102, India.<br /><searchLink fieldCode="AU" term="%22Pallaprolu+N%22">Pallaprolu N</searchLink>; Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER)-Hajipur, Bihar, 844102, India.<br /><searchLink fieldCode="AU" term="%22Peraman+R%22">Peraman R</searchLink>; Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER)-Hajipur, Bihar, 844102, India. drram@niperhajipur.ac.in.
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        Value: 10.1007/s11095-025-03857-9
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              Text: 2025 Apr
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