75463
ICH Q3D口服药ICP元素混标4（2B类）
TraceCERT®, applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland, (in 7% HCl)
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
Au, 300 mg/L , Ir, 100 mg/L , Os, 100 mg/L , Pd, 100 mg/L , Pt, 100 mg/L , Rh, 100 mg/L , Ru, 100 mg/L
manufacturer/tradename
Manufactured by: Sigma-Aldrich Production GmbH, Switzerland
concentration
(in 7% HCl)
technique(s)
ICP: suitable
matrix
HCl
application(s)
pharmaceutical
format
multi-component solution
Quality Level
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.
Search & download your certificate here.
Please visit ISO certificates and Site Quality Self-Assessments to access the current certificates of accreditation.
Search & download your certificate here.
Preparation Note
For the preparation of this CRM only materials of highest purity were used.
Other Notes
Please visit Inorganic Elemental Impurity Mix Standards for a complete product listing of Elemental Impurity Mixes and Single Element Certified Reference Material Solutions
For detailed information for on our newly launched Elemental Impurity Mixes please check the flyer: Elemental Impurities - Certified Reference Materials for ICH Q3D, USP <232> and Ph.Eur. 5.20
In our effort to be more sustainable, we′re going digital with COAs-download them directly from our website.
For detailed information for on our newly launched Elemental Impurity Mixes please check the flyer: Elemental Impurities - Certified Reference Materials for ICH Q3D, USP <232> and Ph.Eur. 5.20
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
Warning
hcodes
Hazard Classifications
Aquatic Chronic 3 - Met. Corr. 1
flash_point_f
Not applicable
flash_point_c
Not applicable
存储类别
12 - Non Combustible Liquids
法规信息
新产品
此项目有
商品
Control elemental impurities in drug products with analytical methods and materials to ensure patient safety.
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