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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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About This Item

Code UNSPSC :
41116107
Nomenclature NACRES :
NA.24

Qualité

certified reference material
TraceCERT®

Niveau de qualité

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

Ba, 70 mg/L
Cr, 110 mg/L
Cu, 30 mg/L
Li, 25 mg/L
Mo, 150 mg/L
Sb, 9 mg/L
Sn, 60 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

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.

Application

Elemental Impurities according to ICH Q3D parenteral, Standard 3 may be used as a reference standard for screening of elemental impurities in pharmaceutical products in compliance with United States Pharmacopoeia (USP) and ICH-Q3D.

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

Pictogrammes

CorrosionExclamation mark

Mention d'avertissement

Danger

Mentions de danger

Classification des risques

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

Risques supp

Code de la classe de stockage

8B - Non-combustible corrosive hazardous materials

Classe de danger pour l'eau (WGK)

WGK 1

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


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