89922
元素杂质混标2，符合ICH Q3D注射用
TraceCERT®, (in 10% hydrochloric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20
别名:
ICH Q3D Elemental Impurity Standard 2
产品名称
元素杂质混标2，符合ICH Q3D注射用, 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, 100 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
Application
Elemental Impurities according to ICH Q3D parenteral can be used as calibration standard for quantitation of elemental impurities in tablets according to the new USP chapters <232> Elemental Impurities – Limits and <233> Elemental Impurities by ICP-OES method.
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.
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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.
Preparation Note
For the preparation of this CRM only materials of highest purity were used.
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
商品
Control elemental impurities in drug products with analytical methods and materials to ensure patient safety.
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