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| Quality Parameter | Specification | Test Method | Compliance |
|---|---|---|---|
| Purity | ≥ 98% | HPLC | USP |
| Appearance | White Powder | Visual Inspection | In House |
| Melting Point | 150-155°C | Melting Point Apparatus | ISO 17025 |
| Moisture Content | ≤ 0.5% | Karl Fischer Titration | ICH |
| Residual Solvents | None Detected | GC | EP |