| Popis: |
This procedure measures impurity levels of ICH Q3D Class 1 and 2A elements (As, Cd, Hg, Pb, Co, Ni, and V) in PQRI Interlab Study tablets. This is the method intended used by all laboratories participating in the PQRI Interlaboratory Study. Samples were acid-digested with nitric acid in a microwave digestion system. The resulting solutions were diluted, and then analyzed by inductively coupled plasma mass spectrometry (ICP-MS) using an external calibration curve and an internal standard specific to each analyte. Results were reported in ppm (μg/g). |
