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

• 동의어(들): TraceCERT Elemental Impurities according to ICH Q3D oral
• 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, 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
• 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

• 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).

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,H412
• 예방조치 성명서: 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
• 보충제 위험성: EUH071
• WGK: WGK 3
• Flash Point (°F): Not applicable
• Flash Point (°C): Not applicable