Analysis by ICP Atomic Emission Spectrometry in Accordance with the ICH Q3D Guideline for Elemental Impurities Using ICPE-9820

At the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH, various guidelines were established and harmonized between Japan, Europe, and the US, including guidelines for elemental impurities in pharmaceuticals, referred to as the ICH Q3D, Guideline for Elemental Impurities. For the analysis of elemental impurities, ICP-AES is the most convenient, offering quick and easy multi-element analysis, and low running costs.
Here, we conducted analysis of 24 elements according to the ICH Q3D guidelines using the Shimadzu ICPE-9820 multi-type ICP atomic emission spectrometer.

Content Type:
Application
Document Number:
LAAN-A-CP-E012A
Product Type:
Elemental Analysis, Inductively Coupled Plasma Emission Spectroscopy
Keywords:
ICH Q3D, USP, EMA, Pharmaceuticals, Element, Impurity, Pharmaceutical, Life Science, Development (Formulation, Scale-up, Method development), ICPE-9820
Language:
English
File Name:
jpb414004.pdf
File Size:
176kb

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For Research Use Only. Not for use in diagnostic procedures.

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