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.
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
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Multielement Standard Solution for Water Quality Analysis
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Multielement Standard Solution for Rock and Soil Analysis
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Multielement Standard Solution for Rare Earth Analysis
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Multielement Standard Solution for ICH Q3D Oral Preparation
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Multielement Standard Solution for ICH Q3D Injection
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Mercury Standard Solution for ICH Q3D (Hg 30)
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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.