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

• Synonym(s): TraceCERT Elemental Impurities according to ICH Q3D oral
• 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, 150 mg/L ; As, 15 mg/L ; Cd, 5 mg/L ; Co, 50 mg/L ; Hg, 30 mg/L ; Ni, 200 mg/L ; Pb, 5 mg/L ; Se, 150 mg/L ; Tl, 8 mg/L ; V, 100 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

• Compatibility of oral magnesium oxide with ICH-Q3D: A study assessing the compatibility of oral magnesium oxide preparations with ICH-Q3D guidelines for elemental impurities ensures compliance with global standards, enhancing drug safety and efficacy (Satoh et al., 2021).

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,H412
• Precautionary Statements: P234 - P273 - P280 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338
• Hazard Classifications: Aquatic Chronic 3 - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
• Supplementary Hazards: EUH071
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable