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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 |