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
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About This Item
NACRES:
NA.24
UNSPSC Code:
41116107
Quality Segment
agency
according to ICH Q3D, according to Ph. Eur., according to USP
product line
TraceCERT®
grade
certified reference material, 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
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.
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.
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
In our effort to be more sustainable, we′re going digital with COAs-download them directly from our website.
In our effort to be more sustainable, we′re going digital with COAs-download them directly from our website.
Legal Information
TraceCERT is a registered trademark of Merck KGaA, Darmstadt, Germany
signalword
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
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