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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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NACRES:
NA.24
UNSPSC Code:
41116107

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产品名称

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

grade

certified reference material
TraceCERT®

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, 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

Quality Level

300

相关类别

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.

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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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Preparation Note

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

Legal Information

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

pictograms

CorrosionExclamation mark
GHS05,GHS07

signalword

Warning

Hazard Classifications

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

target_organs

Respiratory system

存储类别

8B - Non-combustible corrosive hazardous materials

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

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Elemental Impurities - Certified Ref. Materials

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

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