Impurity Profiling in Different Analytical Technique

Registration ID: IJNRD_213720

Published ID: IJNRD2402171

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Vaishnavi Bhagwan Murumkar, Vaishnavi Bhanudas Thorat , Vaishnavi Dattatraya Kakade, Vaishnavi Rajaram Devkar, Dhanashri Kadam

Keywords: Impurity, API, Drug, Identification, Isolation, ICH Guidelines.

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)

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Vaishnavi Bhagwan Murumkar, Vaishnavi Bhanudas Thorat , Vaishnavi Dattatraya Kakade, Vaishnavi Rajaram Devkar, & Dhanashri Kadam (February-2024). Impurity Profiling in Different Analytical Technique. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 9(2), b602-b609. https://ijnrd.org/papers/IJNRD2402171.pdf

Volume 9 Issue 2, February-2024

Pages : b602-b609

Paper Reg. ID: IJNRD_213720

Published Paper Id: IJNRD2402171

Downloads: 000122026

Research Area: Pharmacy

Author Type: Indian Author

Country: Pune, Maharashtra, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2402171.pdf

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