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| Quality Parameter | Measurement Method | Specifications | Compliance Standards |
|---|---|---|---|
| Purity | HPLC | ≥ 98% | USP, EP |
| Moisture Content | Karl Fischer | ≤ 0.5% | ISO 3696 |
| pH Level | Electrometric | 6.5 - 7.5 | ICH Q2(R1) |
| Heavy Metals | AAS | ≤ 10 ppm | FDA, AOAC |
| Storage Conditions | Visual Inspection | Cool, dry place | General Practice |