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Merck
CN

75463

ICH Q3D口服药ICP元素混标4（2B类）

TraceCERT®, applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland, (in 7% HCl)

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NACRES:
NA.24
UNSPSC Code:
41116107

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产品名称

ICH Q3D口服药ICP元素混标4（2B类）, TraceCERT®, applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland, (in 7% HCl)

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, 300 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

manufacturer/tradename

Manufactured by: Sigma-Aldrich Production GmbH, Switzerland

concentration

(in 7% HCl)

technique(s)

ICP: suitable

matrix

HCl

application(s)

pharmaceutical

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.

Search & download your certificate here.

Other Notes

Please visit Inorganic Elemental Impurity Mix Standards for a complete product listing of Elemental Impurity Mixes and Single Element Certified Reference Material Solutions

For detailed information for on our newly launched Elemental Impurity Mixes please check the flyer: Elemental Impurities - Certified Reference Materials for ICH Q3D, USP <232> and Ph.Eur. 5.20

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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

Corrosion
GHS05

signalword

Warning

hcodes

H290,H412

Hazard Classifications

Aquatic Chronic 3 - Met. Corr. 1

存储类别

8B - Non-combustible corrosive hazardous materials

wgk

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable

法规信息

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商品

Elemental Impurities - Certified Ref. Materials

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

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