certified reference material
according to USP
limited shelf life, expiry date on the label
As, 15 mg/L
Cd, 5 mg/L
Hg, 15 mg/L
Pb, 5 mg/L
(in 12% nitric acid)
Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
8B - Non-combustible, corrosive hazardous materials
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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.