IMPURITY PROFILING OF DRUGS: A REVIEW

Registration ID: IJNRD_199445

Published ID: IJNRD2306296

DOI: Click Here to Get

Sakshi D. Wankhade , Gopal M. Shinde , Manoj S. Charde , Rita D. Chakole , Yash B. Kadam

API, Impurity Profiling, Forced Degradation, Sources of Impurities, ICH Guidelines.

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.

Published Paper   E-Certificate

Sakshi D. Wankhade, Gopal M. Shinde, Manoj S. Charde, Rita D. Chakole, & Yash B. Kadam (June-2023). IMPURITY PROFILING OF DRUGS: A REVIEW. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 8(6), c845-c854. https://ijnrd.org/papers/IJNRD2306296.pdf

Volume 8 Issue 6, June-2023

Pages : c845-c854

Paper Reg. ID: IJNRD_199445

Published Paper Id: IJNRD2306296

Downloads: 000121998

Research Area: Pharmacy

Country: Satara, Maharashtra, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2306296.pdf

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