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

• Synonym(s): ICH Q3D Elemental Impurity Analysis Standard
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• 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: 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
• concentration: (in 12% nitric acid)
• technique(s): ICP: suitable
• format: multi-component solution

Description

General description

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.

Application

• 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).

Preparation Note

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

Legal Information

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

Safety Information

• Pictograms: GHS05
• Signal Word: Danger
• Hazard Statements: H290,H314
• Precautionary Statements: P234 - P280 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338 - P363
• Hazard Classifications: Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
• Supplementary Hazards: EUH071
• WGK: WGK 2