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Elemental Impurity Studies
Method development, validation and batch analysis per ICH Q3D and USP.
We provide analysis guidance for elemental impurities as per ICH Q3D in raw materials, drug substances, excipients and drug products, with quick turnaround for method development, method validation and batch analysis.
We develop and validate elemental impurity methods as per USP general chapters <232> and <233>, ICH Q3D, the EMA guideline or your requirements.
Applies to
- Raw materials
- Drug substances
- Excipients
- Drug products