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

• 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: 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
• concentration: in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid )
• technique(s): ICP: suitable
• format: multi-component solution

Description

General description

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.

Application

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]

Preparation Note

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

Other Notes

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

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Legal Information

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

Safety Information

• Pictograms: GHS05,GHS07
• signalword: Danger
• hcodes: H290,H302 + H312,H314
• pcodes: P234 - P280 - P301 + P312 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338
• Hazard Classifications: Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
• supp_hazards: EUH071
• Storage Class: 8B - Non-combustible corrosive hazardous materials
• wgk_germany: WGK 1
• flash_point_f: Not applicable
• flash_point_c: Not applicable