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Key Documents

69729

Supelco

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

Synonym(s):

ICH Q3D oral elemental impurities

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100 MG
CN¥1,241.24

CN¥1,241.24

Available to ship onApril 23, 2025Details

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100 MG
CN¥1,241.24

About This Item

UNSPSC Code:
41116107
NACRES:
NA.24

CN¥1,241.24

Available to ship onApril 23, 2025Details

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

Ba, 140 mg/L
Cr, 1100 mg/L
Cu, 300 mg/L
Li, 55 mg/L
Mo, 300 mg/L
Sb, 120 mg/L
Sn, 600 mg/L

concentration

in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid )

technique(s)

ICP: suitable

format

multi-component solution

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1 of 4

This Item
BX0220319953154628
Benzene Pharmaceutical Secondary Standard; Certified Reference Material

PHR1310

Benzene

Benzene Meets ACS Specifications, Meets Reagent Specifications for testing USP/NF monographs GR ACS

BX0220

Benzene

Benzene ACS reagent, &#8805;99.0%

319953

Benzene

Benzene ACS spectrophotometric grade, &#8805;99%

154628

Benzene

application(s)

pharmaceutical (small molecule)

application(s)

-

application(s)

-

application(s)

-

format

neat

format

-

format

-

format

-

Quality Level

300

Quality Level

200

Quality Level

200

Quality Level

200

grade

certified reference material, pharmaceutical secondary standard

grade

-

grade

ACS reagent

grade

ACS spectrophotometric grade

storage temp.

2-30°C

storage temp.

room temp

storage temp.

-

storage temp.

-

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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Product No.
Description
Pricing

19041

Elemental Impurities according to ICH Q3D oral, Standard 1, TraceCERT®, (in 12% nitric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

73108

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

89922

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

07368

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

89118

Elemental Impurities according to ICH Q3D parenteral, Standard 1, (in 12% nitric acid), TraceCERT®, applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

Pictograms

CorrosionExclamation mark
GHS05,GHS07

Signal Word

Danger

Hazard Statements

H290,H302 + H312,H314

Hazard Classifications

Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B

Supplementary Hazards

EUH071

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.

    Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

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