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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

Synonyme(s) :

ICH Q3D Elemental Impurity Standard 2

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About This Item

Code UNSPSC :
41116107
Nomenclature NACRES :
NA.24

Qualité

certified reference material
TraceCERT®

Niveau de qualité

300

Agence

according to ICH Q3D
according to Ph. Eur.
according to USP

Gamme de produits

TraceCERT®

Durée de conservation

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

Catégories apparentées

Description générale

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.

Notes préparatoires

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

Autres remarques

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.

Informations légales

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

Produit(s) apparenté(s)

Réf. du produit
Description
Tarif

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

Pictogrammes

Corrosion
GHS05

Mention d'avertissement

Warning

Mentions de danger

H290

Conseils de prudence

P234 - P390

Classification des risques

Met. Corr. 1

Code de la classe de stockage

8B - Non-combustible corrosive hazardous materials

Classe de danger pour l'eau (WGK)

WGK 1

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Certificats d'analyse (COA)

Lot/Batch Number

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Elemental Impurities - Certified Ref. Materials

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Elemental Impurities - Certified Ref. Materials

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

Elemental Impurities - Certified Ref. Materials

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

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