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Elemental Impurities according to ICH Q3D oral, Standard 4

TraceCERT®, applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20, (in 7% HCl), Manufactured by: Sigma-Aldrich Production GmbH, Switzerland

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About This Item

UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
TraceCERT®

Quality Level

300

agency

according to ICH Q3D
according to Ph. Eur.
according to USP

product line

TraceCERT®

shelf life

limited shelf life, expiry date on the label

composition

Au, 300 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

manufacturer/tradename

Manufactured by: Sigma-Aldrich Production GmbH, Switzerland

concentration

(in 7% HCl)

technique(s)

ICP: suitable

format

multi-component solution

Related Categories

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.

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

pictograms

Corrosion
GHS05

signalword

Warning

hcodes

H290,H412

Hazard Classifications

Aquatic Chronic 3 - Met. Corr. 1

Storage Class

8B - Non-combustible corrosive hazardous materials

wgk_germany

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable

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Certificates of Analysis (COA)

Lot/Batch Number
BCCK3137

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Articles

Elemental Impurities - Certified Ref. Materials

Control elemental impurities in drug products with analytical methods and materials to ensure patient safety.

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

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