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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

Synonym(s):

ICH Q3D Elemental Impurity Standard 2

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About This Item

NACRES:
NA.24
UNSPSC Code:
41116107
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Quality Level

300

agency

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

product line

TraceCERT®

grade

certified reference material, TraceCERT®

shelf life

limited shelf life, expiry date on the label

composition

Au, 100 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 in accordance with ISO 17034 and characterized in accordance with ISO/IEC 17025. This CRM is traceable to SI unit kg and measured against primary material from a National Metrology Institute (NMI), e.g. NIST.

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Application

Elemental Impurities according to ICH Q3D parenteral can be used as calibration standard for quantitation of elemental impurities in tablets according to the new USP chapters <232> Elemental Impurities – Limits and <233> Elemental Impurities by ICP-OES method.

Preparation Note

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

Other Notes

We provide a diverse range of certified reference materials, including various elemental impurity mixes and single elements, with concentration limits that comply with ICH Q3D guidelines. For more information please visit our Inorganic Elemental Impurity Mix Standards.

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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

12 - Non Combustible Liquids

Certificates of Analysis (COA)

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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.

Global Trade Item Number

SKUGTIN
89922-100ML04061833077375