Volume 15, Issue 8 · IJARST · ISSN 2319-1783 / 2320-1126

A Comprehensive review on Isolation, Characterization and Identification of degradant impurities in Active Pharmaceutical Ingredient

A Comprehensive review on Isolation, Characterization and Identification of degradant impurities in Active Pharmaceutical Ingredient is an open-access, peer-reviewed research paper by Samrudhi D. Bhand, Rupesh A. Pingale*, Pritam P. Khandave*, Pranjal A. Jadhav, Kanchan G. Gawai, published in Volume 15, Issue 8 of the International Journal of Advanced Research in Science and Technology (IJARST), a UGC-approved journal (Print ISSN 2319-1783, Online ISSN 2320-1126).

Author

Samrudhi D. Bhand, Rupesh A. Pingale*, Pritam P. Khandave*, Pranjal A. Jadhav, Kanchan G. Gawai

Abstract

The various drug inventions consist of active pharmaceutical ingredient (API), and its excipients. However, API often contain unwanted impurities that can affect their purity, safety, and effectiveness. Impurity profiling identifies and characterizes all possible impurities, which are generally related to the API, its manufacturing process, as well as stability. The impurities from API can arise from factors such as stereochemistry, crystallization, or functional groups. While related to process impurities contains chemicals, catalysts, residual solvents, intermediates, and by-products formed during synthesis or formulation. Stability-related impurities result from the degradation or interaction of APIs with excipients over time. These impurities can significantly influence the drug’s bioavailability and overall performance. Regulatory authorities like the ICH and USFDA have set strict limits on impurity levels in APIs. Hence, isolating and characterizing impurities using advanced analytical techniques is vital to ensure biological safety and therapeutic efficacy. With growing regulatory emphasis, impurity profiling has now become a mandatory step in new drug development and approval processes, ensuring the production of safe and high-quality pharmaceuticals. This review outlines the potential sources of respect impurities, the need to the impurity profile and the procedures for characterizing as well as identifying impurity. [1]

Keywords: Forced Degradation Study, Degradant impurities, Isolation, Characterization, Identification

DOI: https://doi.org/10.62226/ijarst20262766

 

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DOI

10.62226/ijarst20262766

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How do you cite this paper?

Samrudhi D. Bhand, Rupesh A. Pingale*, Pritam P. Khandave*, Pranjal A. Jadhav, Kanchan G. Gawai — “A Comprehensive review on Isolation, Characterization and Identification of degradant impurities in Active Pharmaceutical Ingredient.” International Journal of Advanced Research in Science and Technology (IJARST), Volume 15, Issue 8. DOI: 10.62226/ijarst20262766.

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