Elemental Impurities
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Metallic Impurities Present in Environmental Water Samples Were Analyzed at Trace Levels Using ICP-MS-KED
Abstract: Elemental impurities in environmental water samples must be carefully monitored since they may have unintended pharmacological and toxicological consequences. For the simultaneous determination of eight metals (Cr, Ni, Cd, Pb, Hg, As, Se, and Sb) in water by ICP-MS, an accurate and sensitive approach has been devised and validated.The method's validity is confirmed through assessment of various criteria for new techniques, including linearity and range, accuracy, precision, selectivity, limit of …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 14, Issue 1, 2023 · pp. 53–58 Read article
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Elemental Impurities: A Review
Abstract: The ICH Q3D is an important guideline to harmonize control of elemental impurities. The guideline sets strict limits for final drug products, limits for excipients, active pharmaceutical ingredients and other pharmaceutical drug products. The analysis of elemental impurities in the pharmaceutical products is most important in pharmaceutical industries. In the last decade noteworthy progress has been made in the analysis of elemental impurities. The changes from using special reagents which …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 11, Issue 1, 2020 · pp. 17–21 Read article