International Journal For Multidisciplinary Research

E-ISSN: 2582-2160   •   Impact Factor: 9.24

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Volume 8 Issue 5
September-October 2026

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Mpurities in Pharmaceutical Elemental Impurities in Pharmaceutical Risk Assessment of Products: A Review Products a Review Elemental Impurities in Pharm

Author(s) Ms Shahitha Afreen, Ms Shafna Tv, Ms Akhil NP
Country India
Abstract Elemental impurities are trace inorganic substances that may enter pharmaceutical products through Poonthavanam post, Perinthalmanna, Malappuram, Kerala – 679325 active pharmaceutical ingredients, excipients, catalysts, manufacturing equipment, water, environmental exposure, and container-closure systems. Their presence is important because toxicity depends on the specific element, dose, route of administration, and duration of exposure. This review summarizes the major sources and classes of elemental impurities, the principles of toxicological evaluation, and the risk-based approach used to assess and control them in pharmaceutical manufacturing. Particular emphasis is placed on the principles of ICH Q3D, including permitted daily exposures (PDEs), route-specific considerations, source identification, risk estimation, analytical verification, and control strategy. Common analytical techniques such as inductively coupled plasma mass spectrometry (ICP-MS) and inductively coupled plasma optical emission spectrometry (ICP-OES) are discussed. The review also considers the role of pharmaceutical quality risk management in supplier qualification, process control, equipment selection, water quality, packaging assessment, and lifecycle monitoring. A structured risk-assessment framework and literature-comparison format are presented to support practical quality assurance applications.
Keywords Elemental impurities; Risk assessment; ICH Q3D; Permitted daily exposure; Heavy metals; ICP-MS; ICP-OES; Pharmaceutical quality; Quality risk management.
Field Medical / Pharmacy
Published In Volume 8, Issue 5, September-October 2026
Published On 2026-09-12
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E-ISSN 2582-2160
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CrossRef DOI prefix of IJFMR is 10.36948/ijfmr

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