The USP<232>/ICH Q3D Class 2B 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 and contains Silver (Ag) at a concentration of 150 µg/mL. It is suitable for use with various instruments requiring multi-element calibration standards.
Product Specifications
| Specification | Details |
|---|---|
| Part Number | IV-STOCK-68-125ML |
| Description | USP<232>/ICH Q3D Class 2B Oral Elemental Impurities |
| Matrix Composition | 5% v/v Nitric Acid |
Elemental Concentration
| Element | Concentration (µg/mL) |
|---|---|
| Silver (Ag) | 150 |
Due to long-term stability concerns, Silver has been separated from the other Class 2B elements. However, IV-STOCK-68 can be combined with IV-STOCK-67 at working levels.
