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)
All active pharmaceutical ingredients contain impurities. Both the purity profile and the impurity
profile are significant factors in the pharmaceutical sector, and both are required by regulatory
authorities. Within the pharmaceutical industry, an impurity is defined as any residual solvent or
other inorganic or organic material that is not part of the medicine and that results from synthesis or
undesired compounds left behind with APIs. The presence of impurities in drugs has a significant
impact on the product’s quality. Impurities come in several forms, including organic and inorganic
ones, as well as starting sources for residual solvents, intermediates, byproducts, and degradation
products. The definitions of impurities in novel drug compounds are provided by the International
Conference on Harmonisation (ICH) guideline.Extremely complex instruments, like mass spectra
metres linked to an HPLC or gas chromatography, are essential tools.The most practical method for
determining residual solvent is gas chromatography (GC)
Keywords:
Keywords: Impurity, API, Drug, Identification, Isolation, ICH Guidelines.
Cite Article:
"Impurity Profiling in Different Analytical Technique", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.9, Issue 2, page no.b602-b609, February-2024, Available :http://www.ijnrd.org/papers/IJNRD2402171.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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