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89922

Supelco

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

Synonym(s):

ICH Q3D Elemental Impurity Standard 2

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10 G
CN¥9,322.21

CN¥9,322.21

Available to ship onApril 17, 2025Details

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10 G
CN¥9,322.21

About This Item

UNSPSC Code:
41116107
NACRES:
NA.24

CN¥9,322.21

Available to ship onApril 17, 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

Au, 100 mg/L
Ir, 10 mg/L
Os, 10 mg/L
Pd, 10 mg/L
Pt, 10 mg/L
Rh, 10 mg/L
Ru, 10 mg/L

concentration

(in 10% hydrochloric acid)

technique(s)

ICP: suitable

format

multi-component solution

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Supelco

10184

Carbosieve Adsorbent

Carbosieve Adsorbent matrix Carbosieve S-II, 60-80&#160;mesh, bottle of 10&#160;g

10189

Carbosieve Adsorbent

Supelco

10199

Carbosieve Adsorbent

Supelco

10197

Carbosieve Adsorbent

particle size

60-80 mesh

particle size

60-80 mesh

particle size

80-100 mesh

particle size

45-60 mesh

pore size

~0.04 cm3/g mesoporosity, ~0 cm3/g macroporosity, ~0.35 cm3/g microporosity, ~4-11 pore diameter

pore size

~0.01 cm3/g mesoporosity, ~0.45 cm3/g microporosity, ~0 cm3/g macroporosity, ~6-15 Å pore diameter

pore size

~0.02 cm3/g mesoporosity, ~0.49 cm3/g microporosity, ~0 cm3/g macroporosity, ~6-15 Å pore diameter

pore size

~0.02 cm3/g mesoporosity, ~0.49 cm3/g microporosity, ~0 cm3/g macroporosity, ~6-15 Å pore diameter

surface area

~975 m2/g

surface area

~1059 m2/g

surface area

~1160 m2/g

surface area

~1160 m2/g

packaging

bottle of 10 g

packaging

bottle of 10 g

packaging

bottle of 5 g

packaging

bottle of 5 g

matrix

Carbosieve™ S-III

matrix

Carbosieve™ S-II

matrix

Carbosieve™ G

matrix

Carbosieve™ G

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.

Application

Elemental Impurities according to ICH Q3D parenteral can be used as calibration standard for quantitation of elemental impurities in tablets according to the new USP chapters <232> Elemental Impurities – Limits and <233> Elemental Impurities by ICP-OES method.[1]

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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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

69729

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

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

Corrosion
GHS05

Signal Word

Warning

Hazard Statements

H290

Precautionary Statements

P234 - P390

Hazard Classifications

Met. Corr. 1

Storage Class Code

8B - Non-combustible corrosive hazardous materials

WGK

WGK 1

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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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