Inspection Item | Standard | Results |
Appearance | White crystalline powder | White crystalline powder |
Identification | Positive | Positive |
Clarity of solution | Clear | Clear |
Color of solution | ≤BY7 | <BY7 |
Assay | 99.0~100.5% | 99.6% |
Loss on Drying | ≤0.4% | 0.04% |
*Residue on ignition | £0.1% | 0.04% |
Specific rotation | +20.5°~ +21.5° | +20.95° |
PH(with 2% water solution) | 2.4-2.8 | 2.64 |
PH(with 5% water solution) | 2.1-2.6 | 2.32 |
Melting range | About 190℃ | 191℃ |
Heavy metals | ≤3ppm | <3ppm |
*Iron | ≤2ppm | <2pp |
*Copper | ≤2ppm | <2ppm |
*Impurity E | ≤0.2% | <0.2% |
*Arsenic | ≤1ppm | <1ppm |
*Lead | ≤2ppm | <2ppm |
*Cadmium | ≤1ppm | <1ppm |
*Mercury | ≤1ppm | <1ppm |
*Organic volatile impurities (As Methanol) | ≤3000ppm | <3000ppm |
*Total Plate Count | ≤1,000cfu/g | <1,000cfu/g |
*Yeast & Moulds | ≤500cfu/g | <500cfu/g |
*Coliforms | Absent in 1g | Absent in 1g |
*E. Coli | Absent in 1g | Absent in 1g |
*Salmonella | Absent in 25g | Absent in 25g |
*Staph Aureus | Absent in 25g | Absent in 25g |
According to BP2016, E300, USP39, FCC 10, EP 8. |
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