The USP<232>/ICH Q3D Class 3 Oral Elemental Impurities Standard is a certified reference material designed for accurate calibration in compliance with USP Method <232> and ICH Q3D guidelines for oral drug products. This standard solution is prepared in a matrix of 5% v/v Nitric Acid with trace Hydrofluoric Acid and contains seven elements at specified concentrations.
Product Specifications
| Specification | Details |
|---|---|
| Part Number | IV-STOCK-69-125ML |
| Description | USP<232>/ICH Q3D Class 3 Oral Elemental Impurities |
| Matrix Composition | 5% v/v Nitric Acid with trace Hydrofluoric Acid |
Elemental Concentrations
| Element | Concentration (µg/mL) |
|---|---|
| Barium (Ba) | 140 |
| Chromium (Cr) | 1100 |
| Copper (Cu) | 300 |
| Lithium (Li) | 55 |
| Molybdenum (Mo) | 300 |
| Antimony (Sb) | 120 |
| Tin (Sn) | 600 |
