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Key Documents

73108

Supelco

Elemental Impurities according to ICH Q3D oral, Standard 2

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

Synonym(s):

ICH Q3D Elemental Impurity Analysis

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0.2 ML
CN¥4,273.58
0.5 ML
CN¥8,903.44

CN¥4,273.58

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0.2 ML
CN¥4,273.58
0.5 ML
CN¥8,903.44

About This Item

UNSPSC Code:
41116107
NACRES:
NA.24

CN¥4,273.58

Please contact Customer Service for Availability
Request a Bulk Order

grade

certified reference material
TraceCERT®

Quality Level

300

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

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technique(s)

indirect ELISA: 1:5,000

technique(s)

indirect ELISA: 1:20,000

technique(s)

indirect ELISA: 1:5,000

technique(s)

indirect ELISA: 1:10,000

conjugate

unconjugated

conjugate

unconjugated

conjugate

unconjugated

conjugate

unconjugated

antibody form

ascites fluid

antibody form

ascites fluid

antibody form

ascites fluid

antibody form

ascites fluid

isotype

IgG2b

isotype

IgG1

isotype

IgG2b

isotype

IgG1

storage temp.

−20°C

storage temp.

−20°C

storage temp.

−20°C

storage temp.

−20°C

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.

Download your certificate at https://www.sigma-aldrich.com to view certified values, including uncertainty, date of expiry, and detailed information about trace impurities.

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

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Elemental Impurities according to ICH Q3D oral, Standard 3, TraceCERT®, in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid ), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

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Elemental Impurities according to ICH Q3D parenteral, Standard 2, TraceCERT®, (in 10% hydrochloric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

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Elemental Impurities according to ICH Q3D parenteral, cutaneous and transcutaneous, Standard 3, TraceCERT®, in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid ), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

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Pictograms

CorrosionExclamation mark
GHS05,GHS07

Signal Word

Warning

Hazard Statements

H290,H315,H335

Hazard Classifications

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

Target Organs

Respiratory system

Storage Class Code

8B - Non-combustible corrosive hazardous materials

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

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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.

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