Mixture Standard Solutions for ICH Q3D

The metal impurity analysis is necessary for the management of metal impurity in many fields, such as impurity element analysis of tap water, ultra‐trace element analysis of semiconductor materials, residual metal analysis of medicine and Biological sample, foods, environment (water/earth), and so on. The instrumental analysis methods (AAS, ICP-OES, and ICP-MS) are mainly used in metal analysis.
FUJIFILM Wako provides mixture standard solutions that can be used for oral and injectable evaluations in the risk assessment of the Guideline for Elemental Impurity (ICH Q3D).

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. And ICH Q3D was considered as one of the ICH issues. FUJIFILM Wako's mixture standard solutions (for ICH Q3D) are compatible with ICH Q3D.

>>Search System for Multi-Element (Metal) Standard Solutions


  • Guarantee of impurity elements by ICP-MS
  • Concentration traceable by JCSS standard or NIST SRM.
  • Concentration confirmation by JCSS or NIST SRM.


Product Code Product Name Composition
138-18801 Multielement Standard Solution
for ICH Q3D Oral Preparation
Cd: 5, Pb: 5, As: 15, Co: 50, V: 100, Ni: 200 (mg/L) 5 w/w% Nitric acid、Oxalic acid dihydrate, Water
135-18811 Multielement Standard Solution
for ICH Q3D Injection
Cd: 2, Pb: 5, As: 15, Co:5, V: 10, Ni: 20, Li: 250, Sb: 90,Cu: 300 (mg/L) 5 w/w% Nitric acid, Oxalic acid dihydrate, L(+)-Tartaric Acid, Water
133-18851 Mercury Standard Solution
for ICH Q3D (Hg 30)
Hg: 30 (mg/L) 5 w/w% Nitric acid, Water

The volume is 100 mL.

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for Oral Preparation

Composition: Ni200、V100、Co50、As15、Cd5、Pb5(mg/L)
Matrix: 5w/w% nitric acid, oxalic acid dihydrate

for Injection

Composition: Ni20、V10、Co5、As15、Cd2、Pb5、Li250、Sb90、Cu300(mg/L)
Matrix: 5w/w% nitric acid, oxalic acid dihydrate, (L)-tartaric acid

Hg 30

Compositions: Hg30(mg/L)
Matrix: 5w/w% nitric acid

Author: A. Samoveanu

For research use or further manufacturing use only. Not for use in diagnostic procedures.

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If the revision of product standards and packaging standards has been made, there is a case where the actual product specifications and images are different.


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