EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

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)

European Journal of Pharmaceutical and Medical Research (EJPMR) has indexed with various reputed international bodies like : 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 (Under Process) , 

 ISSN 2394-3211

Impact Factor: 4.897

 ICV - 79.57

Abstract

PHARMACEUTICAL IMPURITIES AND DEVELOPMENT OF STABILITY INDICATING METHOD (SIM)

Sonali P. Mahaparale* and Bhakti R. Desai

ABSTRACT

There is an ever-increasing interest in impurities which are present in APIs. The presence of impurities in active pharmaceutical ingredients can have a significant impact on the quality, safety & efficacy of pharmaceuticals. Ef-forts should be made to identify, determine and characterize all unknown impurities in the drug, due to the increas-ing demand of regulatory agencies to manufacture and develop high-purity drugs. Drug impurity profiling, i.e. iden-tification, structure elucidation and quantitative determination of impurities, degradation products in bulk drug mate-rials is one of the most important fields of activities in pharmaceutical analysis and manufacturing. The degradation products may be provided through forced degradation studies, which enable development of indicators of stability methods with appropriate specificity and selectivity, provides information about possible degradation routes of a certain product, evaluation of the factors that may interfere in any way in the drug stability and critical analysis of the drug degradation profile. In this review, overview of forced degradation studies and description of different types and origins of impurities in relation to ICH guidelines, degradation routes including specific examples are presented. Also, discusses the current trends related to performance of forced degradation studies by providing a strategy for conducting studies on method development and on degradation mechanisms which is helpful for development of stability indicating method (i.e. SIAM).

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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 (Under Process)