Title:Risk Assessment, Screening and Control of Elemental Impurities in Pharmaceutical Drug Products: A Review
VOLUME: 16 ISSUE: 7
Author(s):Rajesh Kumar Chawla*, Subhranshu Panda, Kulandaivelu Umasankar, Siva Prasad Panda and Dalu Damayanthi
Affiliation:K.L. College of Pharmacy, K.L. University, Vaddeswaram, Guntur, Andhra Pradesh 522502, K.L. College of Pharmacy, K.L. University, Vaddeswaram, Guntur, Andhra Pradesh 522502, K.L. College of Pharmacy, K.L. University, Vaddeswaram, Guntur, Andhra Pradesh 522502, K.L. College of Pharmacy, K.L. University, Vaddeswaram, Guntur, Andhra Pradesh 522502, K.L. College of Pharmacy, K.L. University, Vaddeswaram, Guntur, Andhra Pradesh 522502
Keywords:Risk assessment, Elemental impurities (EIs), Screening and Control, International Conference on Harmonization
(ICH) Q3D guideline, United States Pharmacopoeia (USP) General Chapter <232> & <233>.
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.