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Merck
CN

73108

ICH Q3D口服药元素杂质混标2

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

别名:

ICH Q3D Elemental Impurity Analysis

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关于此项目

NACRES:
NA.24
UNSPSC Code:
41116107
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Quality Level

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, 100 mg/L , Os, 100 mg/L , Pd, 100 mg/L , Pt, 100 mg/L , Rh, 100 mg/L , Ru, 100 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.

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


pictograms

CorrosionExclamation mark

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Warning

Hazard Classifications

Met. Corr. 1 - Skin Irrit. 2 - STOT SE 3

target_organs

Respiratory system

flash_point_f

Not applicable

flash_point_c

Not applicable

存储类别

12 - Non Combustible Liquids



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商品

Control elemental impurities in drug products with analytical methods and materials to ensure patient safety.





全球贸易项目编号

货号GTIN
73108-100ML04061832865522