Heavy metals testing in active pharmaceutical ingredients: an alternate approach
The principle of the pharmacopoeial heavy metals test is detection and estimation of the metallic impurities colored by sulfide ion by comparison against lead standard. The test suffers from a loss of analytes upon ashing and from having varied responses for various metals. An inductively
coupled plasma-optical emission spectroscopy (ICP-OES) for estimating 23 metals in active pharmaceutical ingredients is being proposed. The method covers the metals listed in USP, Ph. Eur and EMEA guidance on “Residues of Metal Catalysts or Metal Reagents”.
Document Type: Research Article
Affiliations: 1: Quality Control Department, Hetero Labs Ltd., Hetero House, Erragadda, Hyderabad, 500078, India, Email: [email protected] 2: Department of Chemistry, Sri Krishna Devaraya University, Anantapur, India 3: Invagen pharmaceuticals Inc, New York, USA
Publication date: 01 January 2010
- Pharmazie is a leading journal in the field of pharmaceutical sciences. As a peer-reviewed scientific journal, Pharmazie is regularly indexed in the relevant databases like Web of science, Journal Citation Reports and many others. The journal is open for submissions from the whole spectrum of pharnaceutical sciences including Pharmaceutical Chemistry, Experimental and Clinical Pharmacology, Drug Analysis, Pharmaceutics, Pharmaceutical Biology, Clinical Pharmacy etc.
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