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Elemental Impurities according to ICH Q3D oral, Standard 2

TraceCERT®, (in 10% hydrochloric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

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Properties

Related Categories Additional Standards, Analytical Standards, Analytical/Chromatography, Application CRMs, Certified Reference Materials (CRMs),
grade   TraceCERT®
shelf life   limited shelf life, expiry date on the label
composition   Au, 100 mg/L
  Ir, 100 mg/L
  Os, 100 mg/L
  Pd, 100 mg/L
  Pt, 100 mg/L
  Rh, 100 mg/L
  Ru, 100 mg/L
concentration   (in 10% hydrochloric acid)

Description

General description

This certified reference material (CRM) is produced and certified in accordance with ISO/IEC 17025 and ISO 17034 (ISO Guide 34). This CRM is traceable to SI unit kg and measured against primary material from an NMI, e.g. NIST or BAM.
Certified content incl. uncertainty and expiry date are given on the certificate.
Download your certificate at: http://www.sigma-aldrich.com.

Preparation Note

For the preparation of this CRM only materials of highest purity were used.

Legal Information

TraceCERT is a registered trademark of Sigma-Aldrich Co. LLC

Safety & Documentation

Safety Information

RIDADR 
UN 1789 8 / PGII

Documents

Certificate of Analysis

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Protocols & Articles

Articles

Elemental Impurities - Certified Reference Materials for ICH Q3D, USP 232, USP 2232, and Ph.Eur. 5.20

Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources. They may be added intentionally in synthesis or may be present as contaminants (e.g., thr...
Ingrid Hayenga
Product Manager Reference Materials,
Keywords: Absorption, Atomic absorption spectroscopy, Inductively coupled plasma, Infrared spectroscopy, Ion-exchange chromatography, Mass spectrometry, Pharmaceutical, Precipitation

Inorganic elemental impurity mixes according to ICH Q3D guidelines

Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources. They may be added intentionally in synthesis, or may be present as contaminants, (e.g., t...
Keywords: Inductively coupled plasma, Infrared spectroscopy, Mass spectrometry, PAGE, Pharmaceutical, Precipitation

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89922 Elemental Impurities according to ICH Q3D parenteral, Standard 2, TraceCERT®, (in 10% hydrochloric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20
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89118 Elemental Impurities according to ICH Q3D parenteral, Standard 1, TraceCERT®, (in 12% nitric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20
19041 Elemental Impurities according to ICH Q3D oral, Standard 1, TraceCERT®, (in 12% nitric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20
69729 Elemental Impurities according to ICH Q3D oral, Standard 3, TraceCERT®, in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid ), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

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