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Elemental Impurities: A ReviewBy Vaibhav S. Adhao, Raju R. Thenge
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 →