EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

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 ISSN 2394-3211

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 ICV - 79.57

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Abstract

GENOTOXIC IMPURITIES IN ACTIVE PHARMACEUTICAL INGREDIENTS

Debabrata Sanyal#*, Jitendra Verdia and Narendra Joshi

ABSTRACT

Impurities in pharmaceuticals are redundant chemical entities that remain with active pharmaceutical ingredients (APIs), or develop during formulation, or upon aging of both API and formulations. Genotoxic impurities are distinguished class of impurities that can induce genetic mutations and/or chromosomal rearrangements at very low levels. Confirming to this threat towards safety of APIs, global regulations are evolved for their control. The article primarily discusses all aspects related with generation, identification, monitoring and control of genotoxic impurities at suitable level for safe intake of pharmaceutical products.

Keywords: Genotoxic impurities.


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SJIF Impact Factor: 7.065

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  All Since 2019
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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing Scholar Article Journal Index (SAJI) International Scientific Indexing ( ISI ) Scope Database Academia

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