The USP<232>/ICH Q3D(R2) Oral Elemental Impurities Standard is a certified reference material designed for accurate calibration in compliance with USP Method <232> and ICH Q3D(R2) guidelines for oral drug products. This standard solution is prepared in a matrix of 20% v/v Hydrochloric Acid and contains multiple elements at specified concentrations.
Product Specifications
| Specification | Details |
|---|---|
| Part Number | IV-STOCK-78-125ML |
| Description | USP<232>/ICH Q3D(R2) Oral Elemental Impurities |
| Matrix Composition | 20% v/v Hydrochloric Acid |
Elemental Concentrations
| Element | Concentration (µg/mL) |
|---|---|
| Silver (Ag) | 15 |
| Arsenic (As) | 1.5 |
| Gold (Au) | 10 |
| Barium (Ba) | 140 |
| Cadmium (Cd) | 0.5 |
| Cobalt (Co) | 5 |
| Chromium (Cr) | 1100 |
| Copper (Cu) | 300 |
| Mercury (Hg) | 3 |
| Iridium (Ir) | 10 |
| Lithium (Li) | 55 |
| Molybdenum (Mo) | 300 |
| Nickel (Ni) | 20 |
| Osmium (Os) | 10 |
| Lead (Pb) | 0.5 |
| Palladium (Pd) | 10 |
| Platinum (Pt) | 10 |
| Rhodium (Rh) | 10 |
| Ruthenium (Ru) | 10 |
| Antimony (Sb) | 120 |
| Selenium (Se) | 15 |
| Tin (Sn) | 600 |
| Thallium (Tl) | 0.8 |
| Vanadium (V) | 10 |
