国外药物杂质与杂质谱研究文献-Impurity profile Significance in Active Pharmaceutical ingredient.pdfVIP

Eurasian Journal of Analytical Chemistry Volume 2, Number 1, 2007 Impurity profile: Significance in Active Pharmaceutical Ingredient Sanjay B. Bari, Bharati R. Kadam, Yogini S. Jaiswal, Atul A. Shirkhedkar Department of Pharmaceutical Chemistry, R. C. Patel College of Pharmacy, Shirpur, Dist: Dhule - 425 405 (MS), India Abstract Various regulatory authorities like ICH, USFDA, Canadian Drug and Health Agency are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredient’s (API’s). Qualification of the impurities is the process of acquiring and evaluating data that establishes biological safety of an individual impurity; thus, revealing the need and scope of impurity profiling of drugs in pharmaceutical research. Identification of impurities is done by variety of Chromatographic and Spectroscopic techniques, either alone or in combination with other techniques. There are different methods for detecting and characterizing impurities with TLC, HPLC, HPTLC, AAS etc. Conventional Liquid Chromatography, particularly, HPLC has been exploited widely in field of impurity profiling; the wide range of detectors, and stationary phases along with its sensitivity and cost- effective separation have attributed to its varied applications. Among the various Planar Chromatographic Methods; TLC is the most commonly used separation technique, for isolation of impurities; due to its ease of operation and low cost compared to HPLC. An advancement of thin layer chromatography HPTLC, is a well-known technique for the impurity isolation. Headspace GC is one of the mos