Case History-The Control of Impurities-A Critical Issue to The Active Pharmaceutical Ingredient

Krishna Sarma Pathy
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Krishna Sarma Pathy: Head QC/QAIPL research centre, India

JOJ Sciences, 2018, vol. 1, issue 4, 59-61

Abstract: The ICH guidelines on impurity have clearly defined the levels of toxic impurities and have become benchmark in establishing impurities in pharmaceutical drug products. The present article summarizes the concept of impurity profiling and presents a case study on impurity profiling of quantification of active pharmaceutical ingredient and impurities in sildenafil citrate purchased via internet and its relative outcomes.

Keywords: JOJ Sciences; joj sciences impact factor; joj material science; molecular biology; juniper publishers: contemporary life science research; genetics; microbiology; neurobiology; plant biology; structural biology and virology; juniper publishers; open access; high impact journals list; high impact journals; scholarly open access journals; peer reivewed journals; junipe publishers review; History; Control; Impurities; Pharmaceutical; Ingredient; Consumers; Oversight; Sildenafil; Generic; Quality; Potency; Drugs; Tremendous; Carcinogenic; Teratogenic; Mutagenic; Quality; Safety; Efficacy; Impurities (search for similar items in EconPapers)
Date: 2018
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Persistent link: https://EconPapers.repec.org/RePEc:adp:oajojs:v:1:y:2018:i:4:p:59-61

DOI: 10.19080/JOJS.2018.01.555566

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