Raghuram P, Soma Raju I V, Sriramulu J
Quality Control Department, Hetero Labs Ltd., Hyderabad, India.
Pharmazie. 2010 Jan;65(1):15-8.
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".
药典重金属检测的原理是通过与铅标准品比较，检测和估算被硫化物离子染色的金属杂质。该检测方法存在灰化时分析物损失以及对各种金属有不同响应的问题。现提出一种用于估算活性药物成分中23种金属的电感耦合等离子体发射光谱法（ICP-OES）。该方法涵盖了美国药典、欧洲药典和欧洲药品管理局（EMEA）关于“金属催化剂或金属试剂残留”指南中列出的金属。
