Multielement Mixture Standard Solutions for ICP Analysis

Trace elements need to be controlled not only in electronic materials and water quality, but also in food and pharmaceuticals. In trace element analysis, simultaneous multielement analysis has become the mainstream.
Fujifilm Wako offers a variety of multielement mixture standard solutions for various measurement purposes, including elements to be measured in water, rock, soil, and rare earth (REE) analysis, and elements to be measured in the evaluation of oral and parenteral drugs for risk assessment in accordance with the Guideline for Elemental Impurities (ICH Q3D). Fujifilm Wako has a wide range of multielement mixture standard solutions for various measurement purposes.

Click here to search for a mixture standard solution by the element to be measured.

Multielement Mixture Standard Solutions for ICP Analysis

Fujifilm Wako offers a variety of multielement mixture standard solutions for ICP analysis, which can be used for environmental analysis, etc.

Features

  • Eliminates the time and labor required to prepare the mixture standard solution.
  • Guaranteed concentration: 100.0 ± 5.0 mg/L* for each element.
*Guaranteed concentrations may differ for some products.

Composition Information

W : for water quality analysis, L : for rock and soil analysis, R : for rare earth analysis

Composition (mg/L) Multielement Standard Solution W-l Multielement Standard Solution W-II Multielement Standard Solution W-III Multielement Standard Solution W-IV Multielement Standard Solution W-V Multielement Standard Solution W-VI Multielement Standard Solution W-X Multielement Standard Solution L-I Multielement Standard Solution R-III
Al - - - - 100 100 100 1,000 -
As - - - - - - 100 - -
B - - - - 100 100 - - -
Ba - - - - - - - 100 -
Be - - - - - - - - -
Ca - 1,000 - - - 100 - 1,000 -
Cd - - 100 100 100 100 100 - -
Co - 100 - - - - - - -
Cr - - 100 100 100 100 100 100 -
Cu - - 1,000 100 100 100 100 - -
Dy - - - - - - - - 100
Er - - - - - - - - 100
Fe - 100 - 100 100 100 - 1,000 -
Ga - - - - - - - - -
Ho - - - - - - - - 100
In - - - - - - - - -
K 2,000 - - - - - - - -
Lu - - - - - - - - 100
Mg - 1,000 - - - 100 - 100 -
Mn - 100 - 100 100 100 100 - -
Mo - - - - 100 - - - -
Na 2,000 - - 100 100 100 - - -
Nd - - - - - - - - -
Ni - 100 - - 100 - - - -
P 1,000 - - - - - - - -
Pb - - 100 100 100 100 100 100 -
Se - - - - - - 100 - -
Sr - - - - - - - 100 -
Tl - - - - - - - - -
Tm - - - - - - - - 100
Y - - - - - - - - -
Yb - - - - - - - - 100
Zn - - 1,000 100 100 100 100 - -
Solvent H2O 1.0 mol/L HNO3 1.0 mol/L HNO3 0.1 mol/L HNO3 1.0 mol/L HNO3 0.1 mol/L HNO3 0.2 mol/L HNO3 1.0 mol/L HNO3 1.0 mol/L HNO3

*Wako product manual is not included with these mixture standard solutions.
*All volumes are 50 mL

Multielement Mixture Standard Solutions for ICH Q3D

Fujiflm Wako offers a variety of mixture standard solutions that can be used to evaluate oral and parenteral drugs for risk assessment in accordance with the Guideline for Elemental Impurities (ICH Q3D). ICH Q3D is one of the issues discussed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Features

  • Guarantee elements other than component elements (impurity elements) using ICP-MS.
  • Concentration is set with reference to the “Permitted Daily Exposure (PDE) for each element of toxicological concern”.
  • Concentration confirmation is performed using JCSS standard solution or NIST SRM.
  • Wako product manual with impurity element information is attached to the product.
Composition (mg/L) Oral Parenteral Inhalation Cutaneous
Class Composition Multielement Standard Solution for ICH Q3D Oral Preparation Multielement Standard Solution for ICH Q3D Injection Mercury Standard Solution for ICH Q3D (Hg 30) PDE (μg/day)* CTCL(μg/g)
1 As 15 15 - 15 15 2 30 -
Cd 5 2 - 5 2 2 20 -
Hg - - 30 30 3 1 30 -
Pb 5 5 - 5 5 5 50 -
2A Co 50 5 - 50 5 3 50 35
Ni 200 20 - 200 20 6 200 35
V 100 10 - 100 10 1 100 -
2B Ag - - - 150 15 7 150 -
Au - - - 300 300 3 3,000 -
Ir - - - 100 10 1 100 -
Os - - - 100 10 1 100 -
Pd - - - 100 10 1 100 -
Pt - - - 100 10 1 100 -
Rh - - - 100 10 1 100 -
Ru - - - 100 10 1 100 -
Se - - - 150 80 130 800 -
Tl - - - 8 8 8 8 -
3 Ba - - - 1,400 700 300 7,000 -
Cr - - - 11,000 1,100 3 11,000 -
Cu - 300 - 3,000 300 30 3,000 -
Li - 250 - 550 250 25 2,500 -
Mo - - - 3,000 1,500 10 15,000 -
Sb - 90 - 1,200 90 20 900 -
Sn - - - 6,000 600 60 6,000 -
Solvent 5 w/w% HNO3 5 w/w% HNO3 5 w/w% HNO3 - - - - -

*As of June 2024

ICH Q3D Classification of Elemental Impurities

Class Classification Contents
1 - Class 1 elements are human toxicants that have limited or no use in the manufacture of pharmaceuticals. These elements require evaluation during the risk assessment, across all potential sources of elemental impurities and routes of administration. The class 1 elements are: As, Cd, Hg, and Pb.
2 A Class 2A elements have relatively high probability of occurrence in the drug product and thus require risk assessment across all potential sources of elemental impurities and routes of administration. The class 2A elements are: Co, Ni, and V.
B Class 2B elements have a reduced probability of occurrence in the drug product related to their low abundance and low potential to be co-isolated with other materials. As a result, they may be excluded from the risk assessment unless they are intentionally added during the manufacture of drug substances, excipients, or other components of the drug product. The class 2A elements are: Ag, Au, Ir, Os, Pd, Pt, Rh, Ru, Se, and Tl.
3 - Class 3 elements have relatively low toxicities by the oral route of administration (high PDEs, generally > 500 µg/day) but may require consideration in the risk assessment for inhalation and parenteral routes. For parenteral and inhalation products, the potential for inclusion of these elemental impurities should be evaluated during the risk assessment, unless the route specific PDE is above 500 µg/day. The class 3 elements are: Ba, Cr, Cu, Li, Mo, Sb, and Sn.
Other Elements Some elemental impurities for which PDEs have not been established due to their low inherent toxicity and/or differences in regional regulations are not addressed in this guideline. The other elements are: Al, B, Ca, Fe, K, Mg, Mn, Na, W, and Zn.

The ICH Q3D Guideline “Recommendations for Elements to be Considered in the Risk Assessment” requires risk assessment of all Class 1, 2A, 2B, and 3 elements for all routes of administration when they are intentionally added regardless of the route of administration. On the other hand, when the elements are not intentionally added, the elements that require risk assessment differ depending on the route of administration.

Elements to be Considered in the Risk Assessment for Unintentional Additions

Class Element Oral Parenteral Inhalation Cutaneous
1 As yes yes yes yes
Cd yes yes yes yes
Hg yes yes yes yes
Pb yes yes yes yes
2A Co yes yes yes yes
Ni yes yes yes yes
V yes yes yes yes
2B Ag no no no no
Au no no no no
Ir no no no no
Os no no no no
Pd no no no no
Pt no no no no
Rh no no no no
Ru no no no no
Se no no no no
Tl no no no no
3 Ba no no yes no
Cr no no yes no
Cu no yes yes no
Li no yes yes no
Mo no no yes no
Sb no yes yes no
Sn no no yes no

Fujifilm Wako offers mixture standard solutions that can be used for oral and parenteral drugs in risk assessment of unintentional additions.

Product List

  • Open All
  • Close All

Multielement Standard Solution for Water Quality Analysis

Now Loading...

Multielement Standard Solution for Rock and Soil Analysis

Now Loading...

Multielement Standard Solution for Rare Earth Analysis

Now Loading...

Multielement Standard Solution for ICH Q3D Oral Preparation

Now Loading...

Multielement Standard Solution for ICH Q3D Injection

Now Loading...

Mercury Standard Solution for ICH Q3D (Hg 30)

Now Loading...

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

Product content may differ from the actual image due to minor specification changes etc.

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.