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Regul Toxicol Pharmacol. 2019 Jul 31;108:104435. doi: 10.1016/j.yrtph.2019.104435. [Epub ahead of print]

Elemental impurities in pharmaceutical products adding fuel to the fire.

Author information

1
Multidisciplinary Research Unit, University Centre of Excellence in Research, Baba Farid University of Health Sciences, Faridkot, 151203, Punjab, India.
2
Multidisciplinary Research Unit, University Centre of Excellence in Research, Baba Farid University of Health Sciences, Faridkot, 151203, Punjab, India. Electronic address: ucer_bfuhs@rediffmail.com.

Abstract

The pharmaceuticals may generate impurities at various stages of development, transportation and storage which make them risky to be administered. Thus, it is essential that these impurities must be detected and quantified. However, their presence as impurities in finished products is virtually unavoidable, even under GMP conditions. Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug products to control based on permitted daily exposures in drug products. Within the pharmaceutical community, there is uncertainty regarding the impact of these changes on manufactures of drug products. This uncertainty is fueled due to lack of publicly available information on elemental impurity levels in common pharmaceutical excipients. The present compilation gives an account of updated information about elemental impurities and reviews the regulatory aspects for such impurities in active pharmaceutical ingredients/drug formulations. In addition, the aim of this article is to review and discuss the currently used quantitative analytical method, which is used for quality control of elemental impurities in pharmaceutical products.

KEYWORDS:

Analytical method; Elemental impurities; Formulations; Guidelines; Pharmaceutical

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