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| Property | Specification | Testing Method | Compliance |
|---|---|---|---|
| Purity | ≥ 98% | HPLC | USP |
| Appearance | White to off-white powder | Visual Inspection | EP |
| Melting Point | 150-155°C | Differential Scanning Calorimetry | ISO 17025 |
| Water Content | ≤ 0.5% | Karl Fischer Titration | ICH |
| Related Substances | Not detected | HPLC | FDA |