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

• Sinónimos: ICH Q3D Elemental Impurity Standard 2
• Código UNSPSC: 41116107
• NACRES: NA.24

Propiedades

• grado: certified reference material; TraceCERT^®
• Nivel de calidad: 300
• Agency: according to ICH Q3D; according to Ph. Eur.; according to USP
• Línea del producto: TraceCERT^®
• caducidad: limited shelf life, expiry date on the label
• composición: 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
• concentración: (in 10% hydrochloric acid)
• técnicas: ICP: suitable
• Formato: multi-component solution

Descripción

Descripción general

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.

Aplicación

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.

Nota de preparación

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

Otras notas

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.

Información legal

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

Información de seguridad

• Pictogramas: GHS05
• Palabra de señalización: Warning
• Frases de peligro: H290
• Consejos de prudencia: P234 - P390
• Clasificaciones de peligro: Met. Corr. 1
• Código de clase de almacenamiento: 8B - Non-combustible corrosive hazardous materials
• Clase de riesgo para el agua (WGK): WGK 1