Journal :   Asian Journal of Research in Chemistry

Volume No. :   9

Issue No. :  5

Year :  2016

Pages :   226-232

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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Review on Guideline on Elemental Impurities



Address:   Poonam R. Songire1, Prof. Smita Aher2*, Prof. Dipti Phadtare2 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
DOI No: 10.5958/0974-4150.2016.00039.0

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.
KEYWORDS:
Elemental impurities, Types of impurities, Control strategy.
Cite:
Poonam R. Songire, Smita Aher, Prof. Dipti Phadtare, Saudagar R. B.. Review on Guideline on Elemental Impurities. Asian J. Research Chem. 2016; 9(5): 226-232.
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