Documents
73108
Elemental Impurities according to ICH Q3D oral, Standard 2
TraceCERT®, (in 10% hydrochloric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20
Recommended Products
grade
certified reference material
TraceCERT®
Quality Level
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, 100 mg/L
Os, 100 mg/L
Pd, 100 mg/L
Pt, 100 mg/L
Rh, 100 mg/L
Ru, 100 mg/L
concentration
(in 10% hydrochloric acid)
technique(s)
ICP: suitable
format
multi-component solution
Related Categories
1 of 4
This Item | 69729 | 89118 | 89922 |
|---|---|---|---|
| shelf life limited shelf life, expiry date on the label | shelf life limited shelf life, expiry date on the label | shelf life limited shelf life, expiry date on the label | shelf life limited shelf life, expiry date on the label |
| concentration (in 10% hydrochloric acid) | concentration in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid ) | concentration (in 12% nitric acid) | concentration (in 10% hydrochloric acid) |
| technique(s) ICP: suitable | technique(s) ICP: suitable | technique(s) ICP: suitable | technique(s) ICP: suitable |
| format multi-component solution | format multi-component solution | format multi-component solution | format multi-component solution |
| Quality Level 300 | Quality Level 300 | Quality Level 300 | Quality Level 300 |
General description
Certified content incl. uncertainty and expiry date are given on the certificate.
Download your certificate at: http://www.sigma-aldrich.com.
Preparation Note
Legal Information
related product
Signal Word
Warning
Hazard Statements
Precautionary Statements
Hazard Classifications
Met. Corr. 1 - Skin Irrit. 2 - STOT SE 3
Target Organs
Respiratory system
Storage Class Code
8B - Non-combustible, corrosive hazardous materials
WGK
WGK 1
Flash Point(F)
Not applicable
Flash Point(C)
Not applicable
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Elemental impurities in drug products pose a risk to patient health due to toxicological effects, and their levels should be controlled within acceptable limits. Find analytical methods and materials for impurity assessment.
In 2009, the International Conference on Harmonization (ICH) proposed the development of a new harmonized guideline to provide a global policy for limiting metal impurities in drug products and ingredients. This approach provides clear regulatory guidance on specification limits for elemental impurities worldwide and logically should have an impact on the work of the national regulatory bodies in having transparent and comparable results.
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