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Key Documents

93696

Supelco

Elemental Impurities according to ICH Q3D inhalation, Standard 2

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

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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, 10 mg/L
Ir, 10 mg/L
Os, 10 mg/L
Pd, 10 mg/L
Pt, 10 mg/L
Rh, 10 mg/L
Ru, 10 mg/L

concentration

(in 10% hydrochloric acid)

technique(s)

ICP: suitable

format

multi-component solution

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.

Analysis Note

The concentrations are 10 fold according to ICH Q3D guideline.

Legal Information

TraceCERT is a registered trademark of Merck KGaA, Darmstadt, Germany

pictograms

Corrosion
GHS05

signalword

Warning

hcodes

H290

Hazard Classifications

Met. Corr. 1

Storage Class

8B - Non-combustible corrosive hazardous materials

wgk_germany

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

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Certificates of Analysis (COA)

Lot/Batch Number
BCCG3856
BCBW9770

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Articles

Inorganic elemental impurity mixes according to ICH Q3D guidelines

In 2009, the International Conference on Harmonization (ICH) proposed the development of a new harmonized guideline to provide a global policy for limiting metal impurities in drug products and ingredients. This approach provides clear regulatory guidance on specification limits for elemental impurities worldwide and logically should have an impact on the work of the national regulatory bodies in having transparent and comparable results.

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