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93696

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

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

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 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.

Analysis Note

The concentrations are 10 fold according to ICH Q3D guideline.

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

pictograms

Corrosion
GHS05

signalword

Warning

hcodes

H290

Hazard Classifications

Met. Corr. 1

flash_point_f

Not applicable

flash_point_c

Not applicable

Storage Class

12 - Non Combustible Liquids

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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
424668-100G04061832103785
93696-100ML04061837105432