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Application
Elemental Impurities according to ICH Q3D parenteral, Standard 3 may be used as a reference standard for screening of elemental impurities in pharmaceutical products in compliance with United States Pharmacopoeia (USP) and ICH-Q3D.[1]
General description
This certified reference material (CRM) is produced in accordance with ISO 17034 and characterized in accordance with ISO/IEC 17025. This CRM is traceable to SI unit kg and measured against primary material from a National Metrology Institute (NMI), e.g. NIST.
Please visit ISO certificates and Site Quality Self-Assessments to access the current certificates of accreditation.
Download your certificate at https://www.sigma-aldrich.com to view certified values, including uncertainty, date of expiry, and detailed information about trace impurities.
Other Notes
We provide a diverse range of certified reference materials, including various elemental impurity mixes and single elements, with concentration limits that comply with ICH Q3D guidelines. For more information please visit our Inorganic Elemental Impurity Mix Standards
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Preparation Note
For the preparation of this CRM only materials of highest purity were used.
Legal Information
TraceCERT is a registered trademark of Merck KGaA, Darmstadt, Germany
