89922
certified reference material
TraceCERT®
according to ICH Q3D
according to Ph. Eur.
according to USP
TraceCERT®
limited shelf life, expiry date on the label
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
(in 10% hydrochloric acid)
ICP: suitable
multi-component solution
Warning
Met. Corr. 1
8B - Non-combustible, corrosive hazardous materials
WGK 1
Not applicable
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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