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The importance of analyzing elemental impurities in pharmaceuticals to ensure drug quality and patient safety. The sources of elemental impurities, regulatory guidelines, and analytical methods used for their detection. Cd formulation laboratory offers reliable and independent elemental impurities analysis services using various techniques such as icp-ms, icp-oes, ic, flaa, xrf, aas, and aes.
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Element Cd Pb As Hg Co V Ni Tl Au Pd Ir Os
Class 1 1 1 1 2A 2A 2A 2B 2B 2B 2B 2B
Oral PDE (μg/day)^5 5 15 30 50 100 200 8 100 100 100
Parenteral PDE (μg/day)
Inhalation PDE (μg/day)
Inductively Coupled Plasma – Mass Spectrometry (ICP-MS)
Inductively Coupled Plasma – Optical Emission Spectroscopy (ICP-OES)
Ion Chromatography (IC)
Flame Atomic Absorption Spectroscopy (FLAA)
X-ray Fluorescence (XRF)
Atomic Absorption Spectrometry (AAS)
Atomic Emission Spectrometry (AES)