Abstract

A REVIEW ON IMPURITY PROFILE & IT'S ANALYTICAL METHOD DEVELOPMENT

Chaudhari Urvashi Rajaram*, Prof. Mitali Dalwadi, Dr. Chainesh Shah and Dr. U. M. Upadyay

ABSTRACT

In API many types of impuity are present during manufacturing. The classification of Impurities is depending on deferent guidelines. According ICH guidelines three types of impuity in API (1) Organic Impurities, (2) Inorganic Impurities, (3) Residual Solvents According general names seven types of impuity in API (1) Intermediates, (2) By products, (3) Penultimate intermediate,(4) Degradation products, (5) Related products, (6) Interaction products & (7) Transformation products. According USP three types of impuity in API (1) Ordinary impuity, (2) Organic volatile Impurities & (3) Impurities in official articles. Many ICH guidelines follow for impurities like Q1A, Q3A, Q3B & Q3C are also including in review article. Many US-FDA & Australian Regulatory guidelines also including in this article. Eight sources of impurities in Medicinal agents like (1) Raw materials used in the Manufacturing Process, (2) Reagents used in the Manufacturing Process, (3) Processes used in the Manufacturing Process, (4) Environment Related Impurities,(5) Defects in the Manufacturing Process, (6) Manufacturing Hazards, (7) Impurities Arising During Storage & (8) Accidental Substitution are added in this article. The Analytical Methodologies are depending on samples selection for analytical Method development, screening of chromatographic condition & phases, commonly the use of the liner solvent strength model of gradient elution & optimization of the approach to fine tune parameters related to ruggedness & robustness. Analytical Method for Identification of impuity is Reference Standard Method, Spectroscopy Method, Separation Method, Isolation Method & Hyphenated Method are also including in this article. In this article (1) Spectroscopic Method like UV, IR, NMR & MS (2) Separation Method like TLC, GC, HPLC, CE, & SFC (3) Isolation Method like CE, HPTLC, Column chromatography & Flash chromatography (4) Hyphenated Method like LC-MS, GC-MS, HPLC-DAD-MS & LC-NMR Method are study in this article. Various Impurities reported in API is also study in this article.

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