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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

Synonym(s):

TraceCERT Elemental Impurities according to ICH Q3D oral

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About This Item

NACRES:
NA.24
UNSPSC Code:
41116107
Technical Service
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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

Ag, 150 mg/L , As, 15 mg/L , Cd, 5 mg/L , Co, 50 mg/L , Hg, 30 mg/L , Ni, 200 mg/L , Pb, 5 mg/L , Se, 150 mg/L , Tl, 8 mg/L , V, 100 mg/L

concentration

(in 12% nitric 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.

Please visit ISO certificates and Site Quality Self-Assessments to access the current certificates of accreditation.

Search & download your certificate here.

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.

In our effort to be more sustainable, we′re going digital with COAs-download them directly from our website.

Legal Information

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

Disclaimer

For U.S. Customers: Contains mercury; Do not place in trash - dispose according to local, state, or federal laws.

pictograms

Corrosion
GHS05

signalword

Danger

Hazard Classifications

Aquatic Chronic 3 - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B

supp_hazards

EUH071

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

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
19041-100ML04061838759795