07368

Elementare Verunreinigungen nach ICH Q3D parenteral, Standard 3

TraceCERT^®, in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid ), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

• UNSPSC-Code: 41116107
• NACRES: NA.24

Eigenschaften

• Qualität: certified reference material; TraceCERT^®
• Qualitätsniveau: 300
• Agentur: according to ICH Q3D; according to Ph. Eur.; according to USP
• Produktlinie: TraceCERT^®
• Haltbarkeit: limited shelf life, expiry date on the label
• Zusammensetzung: Ba, 70 mg/L ; Cr, 110 mg/L ; Cu, 30 mg/L ; Li, 25 mg/L ; Mo, 150 mg/L ; Sb, 9 mg/L ; Sn, 60 mg/L
• Konzentration: in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid )
• Methode(n): ICP: suitable
• Format: multi-component solution

Beschreibung

Allgemeine Beschreibung

This certified reference material (CRM) is produced in accordance with ISO 17034 and characterized in accordance with ISO/IEC 17025. This CRM is traceable to SI unit kg and measured against primary material from a National Metrology Institute (NMI), e.g. NIST.

Please visit ISO certificates and Site Quality Self-Assessments to access the current certificates of accreditation.

Download your certificate at https://www.sigma-aldrich.com to view certified values, including uncertainty, date of expiry, and detailed information about trace impurities.

Anwendung

Elemental Impurities according to ICH Q3D parenteral, Standard 3 may be used as a reference standard for screening of elemental impurities in pharmaceutical products in compliance with United States Pharmacopoeia (USP) and ICH-Q3D.[1]

Angaben zur Herstellung

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

Sonstige Hinweise

We provide a diverse range of certified reference materials, including various elemental impurity mixes and single elements, with concentration limits that comply with ICH Q3D guidelines. For more information please visit our Inorganic Elemental Impurity Mix Standards

In our effort to be more sustainable, we′re going digital with COAs-download them directly from our website.

Rechtliche Hinweise

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

Sicherheitshinweise

• Piktogramme: GHS05,GHS07
• Signalwort: Danger
• H-Sätze: H290,H302 + H312,H314
• P-Sätze: P234 - P280 - P301 + P312 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338
• Gefahreneinstufungen: Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
• Zusätzliche Gefahrenhinweise: EUH071
• Lagerklassenschlüssel: 8B - Non-combustible corrosive hazardous materials
• WGK: WGK 1
• Flammpunkt (°F): Not applicable
• Flammpunkt (°C): Not applicable