Identification and validation of potential genotoxic impurities, 1,3‐dichloro‐2‐propanol, and 2,3‐dichloro‐1‐propanol, at subtle levels in a bile acid sequestrant, colesevelam hydrochloride, using hyphenated GC

Identification and validation of potential genotoxic impurities, 1,3‐dichloro‐2‐propanol, and 2,3‐dichloro‐1‐propanol, at subtle levels in a bile acid sequestrant, colesevelam hydrochloride, using hyphenated GC–MS technique

Published:2022-10-29 Issue:1 Volume:37 Page:
ISSN:0269-3879
Container-title:Biomedical Chromatography
language:en
Short-container-title:Biomedical Chromatography

Author:

Kumar S. R. Jythesh¹²,Reddy Junuthula Venkata Ramana²,Rao Vandavasi Koteswara¹^ORCID

Affiliation:

1. Department of Chemistry GITAM School of Science Hyderabad Telangana India

2. Department of Analytical Research Aurobindo Pharma Limited Research Center‐II, Indrakarn (V), Kandi (M) Sangareddy Telangana India

Publisher

Wiley

Subject

Clinical Biochemistry,Drug Discovery,Pharmacology,Molecular Biology,General Medicine,Biochemistry,Analytical Chemistry

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/bmc.5528

Reference19 articles.

1. Simultaneous Determination of Genotoxic Impurities in Fudosteine Drugs by GC–MS

2. Deductive Estimation of Risk from Existing Knowledge (DEREK) nexus. (2019).marketed by LHASA Ltd Leeds Yorkshire UK DEREK Version Derek: 3.0.1; Nexus.

3. International Journal of Pharmaceutical Sciences and Research

4. Genotoxic and Carcinogenic impurities in Drug Substances and products. (2008).US Department of Health and Human services Rockville MD.

5. Colesevelam hydrochloride: Reducing atherosclerotic coronary heart disease risk factors;Harold B.;Vascular Health and Risk Management,2007

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