Neotron Pharma SpA offer service "Elemental Impurities"
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Service Name
Elemental Impurities
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Specifications
- Test Method: ICP-MS/ICP-OES quantitation of elemental impurities against ICH Q3D Class 1, 2A, 2B and 3 element panels.
- Accreditation Standard: Testing performed under an established GMP/ISO 17025-aligned quality system with decades of metals-analysis experience.
- Turnaround Time: Standard reporting turnaround of approximately 2-3 weeks, with expedited options available for urgent risk-assessment needs.
- Sample Type: Applicable to active pharmaceutical ingredients, finished pharmaceutical products, and excipients.
- Detection Limit: Method sensitivity down to sub-ppm levels for most target elements, meeting ICH Q3D permitted daily exposure thresholds.
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