07368

Elemental Impurities according to ICH Q3D parenteral, cutaneous and transcutaneous, 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

• Codice UNSPSC: 41116107
• NACRES: NA.24

Proprietà

• Grado: certified reference material; TraceCERT^®
• Livello qualitativo: 300
• agenzia: according to ICH Q3D; according to Ph. Eur.; according to USP
• Nome Commerciale: TraceCERT^®
• Durata: limited shelf life, expiry date on the label
• Composizione: 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
• Concentrazione: in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid )
• tecniche: ICP: suitable
• Formato: multi-component solution

Descrizione

Descrizione generale

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.

Applicazioni

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]

Nota sulla preparazione

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

Altre note

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.

Note legali

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

Informazioni sulla sicurezza

• Pittogrammi: GHS05,GHS07
• Avvertenze: Danger
• Indicazioni di pericolo: H290,H302 + H312,H314
• Consigli di prudenza: P234 - P280 - P301 + P312 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338
• Classi di pericolo: Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
• Rischi supp: EUH071
• Codice della classe di stoccaggio: 8B - Non-combustible corrosive hazardous materials
• Classe di pericolosità dell'acqua (WGK): WGK 1
• Punto d’infiammabilità (°F): Not applicable
• Punto d’infiammabilità (°C): Not applicable