Asian Journal of Research in Chemistry

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Review on Guideline on Elemental Impurities


Affiliations
1 Department of Quality Assurance Technique, R.G. Sapkal college of Pharmacy, Anjaneri, Nashik, Maharashtra, India
2 Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik, Maharashtra, India
     

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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.
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  • Review on Guideline on Elemental Impurities

Abstract Views: 230  |  PDF Views: 1

Authors

Poonam R. Songire
Department of Quality Assurance Technique, R.G. Sapkal college of Pharmacy, Anjaneri, Nashik, Maharashtra, India
Smita Aher
Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik, Maharashtra, India
Dipti Phadtare
Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik, Maharashtra, India
R. B. Saudagar
Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik, Maharashtra, India

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.