ICH Q3D Elemental Impurities Analysis of Tablets by EDX - Verification Based on USP <233> ELEMENTAL IMPURITIES-PROCEDURES -

In the United States, the United States Pharmacopoeia General Test Chapters USP <232> and <233> have been applied to new drug products since January 1, 2018. ICP-MS and ICP-AES are recommended as the analysis procedures in the chapters. However, the alternative procedure can be substituted for them if the validation requirements are met.
Therefore, the appropriateness of Energy Dispersive X-ray Fluorescence Spectrometer EDX-7000 was verified referring to "Limit Procedures" in USP <233> by evaluating of elemental impurities in oral drug (tablets).

Content Type:
Application
Document Number:
X273
Product Type:
Elemental Analysis, Energy Dispersive X-ray Fluorescence Spectroscopy
Keywords:
EDX, elemental impurities, ICHQ3D, PDE, Permitted Daily Exposure, drug, oral drug, tablets, validation, Class1, Class2A, Class2B, As, Hg, Pb, Cd, V, Co, Ni, Pd, USP <232>, USP <233>, Limit Procedures, Specificity, Precision Repeatability, option 3, alternative procedure, Food and Beverages, Pharmaceutical, Life Science, EDX-7000
Language:
English
File Name:
jpq220009.pdf
File Size:
223kb

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