产品名称
ICH Q3D吸入元素杂质混标2, TraceCERT®, (in 10% hydrochloric acid), 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
Au, 10 mg/L
Ir, 10 mg/L
Os, 10 mg/L
Pd, 10 mg/L
Pt, 10 mg/L
Rh, 10 mg/L
Ru, 10 mg/L
concentration
(in 10% hydrochloric acid)
technique(s)
ICP: suitable
format
multi-component solution
Quality Level
相关类别
Analysis Note
The concentrations are 10 fold according to ICH Q3D guideline.
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.
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
Warning
hcodes
pcodes
Hazard Classifications
Met. Corr. 1
存储类别
8B - Non-combustible corrosive hazardous materials
wgk
WGK 1
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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