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Elemental Impurities according to ICH Q3D oral, Standard 1

SIAL/19041 - TraceCERT®, (in 12% nitric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

Synonym: TraceCERT Elemental Impurities according to ICH Q3D oral

Product Type: Chemical

Catalog Number PKG Qty. Price Quantity
45-19041-100ML 100 mL
$318.00
1/EA
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agency according to ICH Q3D
  according to Ph. Eur.
  according to USP
composition Ag, 150 mg/L
  As, 15 mg/L
  Cd, 5 mg/L
  Co, 50 mg/L
  Hg, 30 mg/L
  Ni, 200 mg/L
  Pb, 5 mg/L
  Se, 150 mg/L
  Tl, 8 mg/L
  V, 100 mg/L
concentration (in 12% nitric acid)
format multi-component solution
grade TraceCERT®
  certified reference material
product line TraceCERT®
Quality Level 300 
shelf life limited shelf life, expiry date on the label
technique(s) ICP: suitable
Application:

  • Compatibility of oral magnesium oxide with ICH-Q3D: A study assessing the compatibility of oral magnesium oxide preparations with ICH-Q3D guidelines for elemental impurities ensures compliance with global standards, enhancing drug safety and efficacy (Satoh et al., 2021 ).

General description: This certified reference material (CRM) is produced and certified in accordance with ISO/IEC 17025 and ISO 17034). This CRM is traceable to SI unit kg and measured against primary material from an NMI, e.g. NIST.
Certified content incl. uncertainty and expiry date are given on the certificate.
Download your certificate at: http://www.sigma-aldrich.com.
Legal Information: TraceCERT is a registered trademark of Merck KGaA, Darmstadt, Germany
Preparation Note: For the preparation of this CRM only materials of highest purity were used.
UNSPSC 41116107

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