69729
Elemental Impurities according to ICH Q3D oral, 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
Synonym(s):
ICH Q3D oral elemental impurities
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About This Item
grade
certified reference material, TraceCERT®
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, 140 mg/L , Cr, 1100 mg/L , Cu, 300 mg/L , Li, 55 mg/L , Mo, 300 mg/L , Sb, 120 mg/L , Sn, 600 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
Quality Level
Related Categories
General description
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Preparation Note
Other Notes
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Legal Information
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Danger
hcodes
Hazard Classifications
Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
supp_hazards
Storage Class
8B - Non-combustible corrosive hazardous materials
flash_point_f
Not applicable
flash_point_c
Not applicable
Certificates of Analysis (COA)
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Articles
Control elemental impurities in drug products with analytical methods and materials to ensure patient safety.
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