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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

Signal Word

Warning

Hazard Statements

H290

Precautionary Statements

P234 - P390

Hazard Classifications

Met. Corr. 1

Storage Class Code

8B - Non-combustible corrosive hazardous materials

WGK

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

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

Elemental impurities in drug products pose a risk to patient health due to toxicological effects, and their levels should be controlled within acceptable limits. Find analytical methods and materials for impurity assessment.

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