产品名称
元素杂质混标1,符合ICH Q3D注射用, (in 12% nitric acid), TraceCERT®, applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20
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
Ag, 10 mg/L
As, 15 mg/L
Cd, 2 mg/L
Co, 5 mg/L
Hg, 3 mg/L
Ni, 20 mg/L
Pb, 5 mg/L
Se, 80 mg/L
Tl, 8 mg/L
V, 10 mg/L
concentration
(in 12% nitric acid)
technique(s)
ICP: suitable
format
multi-component solution
Quality Level
Other Notes
我们提供一系列的有证标准物质,包括各种元素杂质混合物和单种元素,浓度限度符合ICH Q3D指导原则要求。详情参见无机元素杂质混合标准品。
为了配合可持续发展宗旨,我们将数字化COA以从我们的网站直接下载。
为了配合可持续发展宗旨,我们将数字化COA以从我们的网站直接下载。
Preparation Note
本 CRM 的制备仅使用了最高纯度的材料。
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.
Legal Information
TraceCERT is a registered trademark of Merck KGaA, Darmstadt, Germany
signalword
Danger
hcodes
Hazard Classifications
Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
supp_hazards
wgk
WGK 2
商品
Control elemental impurities in drug products with analytical methods and materials to ensure patient safety.
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