69729
ICH Q3D口服药元素杂质混标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
别名:
ICH Q3D口服元素杂质
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
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
为制备这种CRM，仅可使用最高纯度的材料。
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。
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
存储类别
8B - Non-combustible corrosive hazardous materials
flash_point_f
Not applicable
flash_point_c
Not applicable
商品
Control elemental impurities in drug products with analytical methods and materials to ensure patient safety.
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