| Items | Standard | Test |
|---|---|---|
| Appearance | White crystalline powder | USP |
| Identification | Positive | USP |
| Clarity of solution | Clear | EP |
| Color of solution | ≤ BY7 | EP |
| Assay | 99.0~100.5% | USP |
| Loss on Drying | ≤ 0.4% | E300 |
| Residue on ignition | ≤ 0.1% | USP |
| Specific rotation | 20.5°~21.5° | USP |
| PH(with 2% water solution) | 2.4-2.8 | E300 |
| PH(with 5% water solution) | 2.1-2.6 | EP |
| Melting range | About 190°C | EP |
| Heavy metals | ≤ 3ppm | USP |
| Iron | ≤ 2ppm | EP |
| Copper | ≤ 2ppm | EP |
| Impurity E | ≤ 0.2% | EP |
| Arsenic | ≤ 1ppm | USP |
| Lead | ≤ 1ppm | FCC |
| Cadmium | ≤ 1ppm | |
| Mercury | ≤ 0.1ppm | E300 |
| Organic volatile impurities | Methanol ≤ 3000ppm | USP |
| Related Substances |
Impurity C ≤ 0.15% Impurity D ≤ 0.15% Any Other Unspecific Impurity ≤ 0.10% Total Impurity ≤ 0.2% |
EP |
| Total Plate Count | ≤ 1,000cfu/g | |
| According to BP2021/USP43/FCC12/EP10/E300 |
