07368
Elemental Impurities according to 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
grade
certified reference material
TraceCERT®
Quality Level
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
Related Categories
General description
Certified content incl. uncertainty and expiry date are given on the certificate.
Download your certificate at: http://www.sigma-aldrich.com.
Preparation Note
Legal Information
related product
Signal Word
Danger
Hazard Statements
Precautionary Statements
Hazard Classifications
Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
Supplementary Hazards
Storage Class Code
8B - Non-combustible, corrosive hazardous materials
WGK
WGK 1
Flash Point(F)
Not applicable
Flash Point(C)
Not applicable
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Articles
Elemental impurities in drug products pose a risk to patient health due to toxicological effects, and their levels should be controlled within acceptable limits. Find analytical methods and materials for impurity assessment.
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