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

• 동의어(들): ICH Q3D Elemental Impurity Analysis Standard
• UNSPSC 코드: 41116107
• NACRES: NA.24

속성

• Grade: certified reference material
• Quality Level: 300
• Agency: according to ICH Q3D; according to Ph. Eur.; according to USP
• 제품 라인: TraceCERT^®
• grade: TraceCERT^®
• 유통기한: limited shelf life, expiry date on the label
• 구성: 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
• 농도: (in 12% nitric acid)
• 기술: ICP: suitable
• 형식: multi-component solution

설명

일반 설명

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.

애플리케이션

• 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).

제조 메모

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

법적 정보

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

안전성 정보

• 픽토그램: GHS05
• 신호어: Danger
• 유해 및 위험 성명서: H290,H314
• 예방조치 성명서: P234 - P280 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338 - P363
• Hazard Classifications: Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
• 보충제 위험성: EUH071
• WGK: WGK 2