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".
Raghuram
P
P
Quality Control Department, Hetero Labs Ltd., Hyderabad, India. ramp.raghu@gmail.com
Soma Raju
I V
IV
Sriramulu
J
J
D000143:Acids; D002384:Catalysis; D005060:Europe; D006861:Hydrogen Peroxide / Q000737:chemistry; D007202:Indicators and Reagents; D000077287:Levetiracetam; D019216:Metals, Heavy / Q000032:analysis*; D008872:Microwaves; D009569:Nitric Oxide / Q000737:chemistry; D004364:Pharmaceutical Preparations / Q000032:analysis*; D010602:Pharmacopoeias as Topic; D010889:Piracetam / Q000031:analogs & derivatives / Q000032:analysis; D012015:Reference Standards; D012996:Solutions; D013052:Spectrometry, X-Ray Emission; D014481:United States
D000143:Acids; D007202:Indicators and Reagents; D019216:Metals, Heavy; D004364:Pharmaceutical Preparations; D012996:Solutions; D009569:Nitric Oxide; D000077287:Levetiracetam; D006861:Hydrogen Peroxide; D010889:Piracetam