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| Quality Parameter | Specification | Test Method | Compliance |
|---|---|---|---|
| Purity | ≥ 98% | HPLC | ISO 9001 |
| Appearance | White to Off-White Powder | Visual Inspection | FDA Approved |
| Moisture Content | ≤ 0.5% | Karl Fischer Titration | USP |
| pH Value | 5.0 - 7.0 | pH Meter | EP |
| Heavy Metals | ≤ 10 ppm | AAS | ICH Guidelines |