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ISSN Approved Journal No: 2455-2631 | Impact factor: 8.15 | ESTD Year: 2016
open access , Peer-reviewed, and Refereed Journals, Impact factor 8.15

Issue: June 2024

Volume 9 | Issue 6

Impact factor: 8.15

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Paper Title: A Review on Impurity Profile in Pharmaceutical Ingredients.
Authors Name: Jaypal Gawai , Dr. Prasad Gorde , Mr.Tushar Akhare , Darshana Shende
Unique Id: IJSDR2405004
Published In: Volume 9 Issue 5, May-2024
Abstract: Abstract for a drug impurity profile in pharmaceutical ingredients provides a concise summary of the impurities present in a specific pharmaceutical ingredient. It typically includes the following information Pharmaceutical ingredient: Specifies the name and identity of the active pharmaceutical ingredient (API) or excipient being evaluated for impurities. Impurity identification: Summarizes the impurities identified in the pharmaceutical ingredient. This can include information about impurity classes, chemical structures, and their origin (e.g., process-related impurities, degradation products). Impurity levels: Provides an overview of the impurity levels found in the ingredient, including qualitative assessments of impurity abundance or quantitative values indicating impurity concentrations. Analytical methods: Describes the analytical techniques used for impurity identification and quantification, such as high-performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), or nuclear magnetic resonance (NMR). Risk assessment: Includes a brief assessment of the potential risks associated with impurities detected in the pharmaceutical ingredient, considering factors like safety, toxicity, Quality control measures: Highlights any quality control measures implemented to address impurities genotoxicity, carcinogenicity, and regulatory thresholds or limits. Impurity is defined as any substance coexisting with the original drug, such as starting material or intermediates or that is formed, due to any side reactions. Impurity can be of three types: Impurities closely related to the product and coming from the chemical or from the biosynthetic route itself, Impurities formed due to spontaneous decomposition of the drug during the storage or on exposure to extreme conditions, or the precursors which may be present in the final product as impurities.
Keywords: Impurities, HPLC, NMR, GC, MS, FDA, EMA, Humidity, Applications, Analytical Procedure
Cite Article: "A Review on Impurity Profile in Pharmaceutical Ingredients.", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.9, Issue 5, page no.43 - 49, May-2024, Available :http://www.ijsdr.org/papers/IJSDR2405004.pdf
Downloads: 000342234
Publication Details: Published Paper ID: IJSDR2405004
Registration ID:211110
Published In: Volume 9 Issue 5, May-2024
DOI (Digital Object Identifier):
Page No: 43 - 49
Publisher: IJSDR | www.ijsdr.org
ISSN Number: 2455-2631

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