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

• Sinónimos: ICH Q3D Elemental Impurity Analysis Standard
• 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: Ag, 10 mg/L ; As, 15 mg/L ; Cd, 2 mg/L ; Co, 5 mg/L ; Hg, 3 mg/L ; Ni, 20 mg/L ; Pb, 5 mg/L ; Se, 80 mg/L ; Tl, 8 mg/L ; V, 10 mg/L
• concentración: (in 12% nitric acid)
• técnicas: ICP: suitable
• formato: multi-component solution

Descripción

Descripción general

This certified reference material (CRM) is produced and certified in accordance with ISO/IEC 17025 and ISO 17034. This CRM is traceable to SI unit kg and measured against primary material from an NMI, e.g. NIST.
Certified content incl. uncertainty and expiry date are given on the certificate.
Download your certificate at: http://www.sigma-aldrich.com.

Aplicación

• Application of ICH Guidelines for the Assessment and Control of Elemental Impurities in Parecoxib Sodium by Graphite-Digestion and ICP-MS: This research demonstrates the application of ICH Q3D guidelines for evaluating elemental impurities in parenteral formulations, specifically using graphite-digestion and ICP-MS techniques on Parecoxib Sodium. This approach ensures compliance with pharmaceutical safety standards, emphasizing its critical role in maintaining drug quality and patient safety (Hao et al., 2022).

Nota de preparación

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

Información legal

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

Información de seguridad

• Pictogramas: GHS05
• Palabra de señalización: Danger
• Frases de peligro: H290,H314
• Consejos de prudencia: P234 - P280 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338 - P363
• Clasificaciones de peligro: Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
• Riesgos supl.: EUH071
• Clase de riesgo para el agua (WGK): WGK 2