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Asian Journal of Research in Chemistry
Year : 2016, Volume : 9, Issue : 5
First page : ( 226) Last page : ( 232)
Print ISSN : 0974-4169. Online ISSN : 0974-4150.
Article DOI : 10.5958/0974-4150.2016.00039.0

Review on Guideline on Elemental Impurities

Songire Poonam R.1, Prof. Aher Smita2,*, Prof. Phadtare Dipti2, Dr. Saudagar R. B.2

1Department of Quality Assurance Technique, R.G. Sapkal college of Pharmacy, Anjaneri, Nashik, Maharashtra, India

2Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik, Maharashtra, India

*Corresponding Author E-mail: poonamsongire1@gmail.com

Online published on 21 June, 2016.

Abstract

Abstract are related to the elemental impurities it included identification, structural elucidation and quantitative determination of impurities. It included According to ICH guidelines, Impurities associated with APIs are classified into the categories. In elemental impurities Four-step process to assess and control elemental impurities in the drug product. Identification of impurities is done by variety of Chromatographic and Spectroscopic techniques, either alone or in combination with other techniques. These impurities are control with strategy.

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Keywords

Elemental impurities, Types of impurities, Control strategy.

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