19041
Elemental Impurities according to ICH Q3D oral, Standard 1
TraceCERT®, (in 12% nitric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20
Synonym(s):
TraceCERT Elemental Impurities according to ICH Q3D oral
About This Item
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
Ag, 150 mg/L
As, 15 mg/L
Cd, 5 mg/L
Co, 50 mg/L
Hg, 30 mg/L
Ni, 200 mg/L
Pb, 5 mg/L
Se, 150 mg/L
Tl, 8 mg/L
V, 100 mg/L
concentration
(in 12% nitric acid)
technique(s)
ICP: suitable
format
multi-component solution
Related Categories
General description
Certified content incl. uncertainty and expiry date are given on the certificate.
Download your certificate at: http://www.sigma-aldrich.com.
Application
- Compatibility of oral magnesium oxide with ICH-Q3D: A study assessing the compatibility of oral magnesium oxide preparations with ICH-Q3D guidelines for elemental impurities ensures compliance with global standards, enhancing drug safety and efficacy (Satoh et al., 2021).
Preparation Note
Legal Information
related product
signalword
Danger
hcodes
Hazard Classifications
Aquatic Chronic 3 - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
supp_hazards
wgk_germany
WGK 3
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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