INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016
Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI)
Something that is impure or makes something else impure is considered to be impure. The definition of an impure substance is as follows: a substance of interest that has been combined with or impregnated with a foreign or typically inferior substance. From the point of view of its intended use, the drug substance is im-pure even if it contains a different substance that has superior pharmacological or toxicological properties. The impurity may appear during formulation or after both raw APIs and formed APIs have aged in pharma-ceutical products. Even a little amount of these undesirable compounds can have an impact on the safety and effectiveness of medicinal goods. The impurities are not always worse than the pure materials. In order to identify small components (drugs, contaminants, degradation products, and metabolites) in varied matrices, very sophisticated instrumentation, such as mass spectra metres connected to a Gas Chromatography or HPLC, is a must. The impurities found in APIs are discussed in this article, along with methods for recognis-ing them and potential solutions for dealing with the interferences they cause in pharmaceutical analysis.
Keywords:
API, Impurity Profiling, Forced Degradation, Sources of Impurities, ICH Guidelines.
Cite Article:
"IMPURITY PROFILING OF DRUGS: A REVIEW", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.8, Issue 6, page no.c845-c854, June-2023, Available :http://www.ijnrd.org/papers/IJNRD2306296.pdf
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ISSN:
2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
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