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Risk Assessment, Screening and Control of Elemental Impurities in Pharmaceutical Drug Products: a Review

Author(s):

Rajesh Kumar Chawla*, Subhranshu Panda, K. Umasankar, Siva Prasad Panda and D. Damayanthi   Pages 1 - 5 ( 5 )

Abstract:


This article describes and reviews the steps involved in risk assessment of the twenty-four (24) potential elemental impurities in pharmaceutical drug products, as per the permitted daily exposure limits. Screening and estimation of prescribed elemental impurities in pharmaceutical drug substances, inactive excipients and drug products by Inductively Coupled Plasma Mass Spectrometry or Inductively Coupled Plasma Optical Emission Spectrometry and their controls involved are also reviewed, as referred in the general chapters <232> & <233> of the United States Pharmacopoeia, Q3D guideline for Elemental Impurities as per International Conference on Harmonization and Q3D Elemental Impurities: guidance for Industry as per U. S., Food and Drug Administration USFDA.

Keywords:

Risk assessment, Elemental impurities (EIs), Screening and Control, International Conference on Harmonization (ICH) Q3D guideline, United States Pharmacopoeia (USP) General Chapter <232> & <233>

Affiliation:

K. L. College of Pharmacy, K. L. University, Vaddeswaram, Guntur, Andhra Pradesh, K. L. College of Pharmacy, K. L. University, Vaddeswaram, Guntur, Andhra Pradesh, K. L. College of Pharmacy, K. L. University, Vaddeswaram, Guntur, Andhra Pradesh, K. L. College of Pharmacy, K. L. University, Vaddeswaram, Guntur, Andhra Pradesh, K. L. College of Pharmacy, K. L. University, Vaddeswaram, Guntur, Andhra Pradesh



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