Item | Specification |
Appearance | White or almost white, hygroscopic powder |
Item | Specification |
Appearance | White or off-white crystalline powder |
Specific rotation | -28.0°~-34.0° |
Crystal form | It should be crystalline Ⅰ, with 2-theta angles of 14.4±0.2°,19.2±0.2°,21.7±0.2°,24.3±0.2°29.3±0.2° |
Identification | IR, HPLC |
Related substances I | PO-R1 NMT 0.10% |
PO-R2 NMT 0.10% | |
PO-R3 NMT 0.10% | |
PO-R4 NMT 0.10% | |
PO-D3 & PO-D5 NMT 0.10% | |
PO-D7 & PO-D10 NMT 0.10% | |
Each of unspecified impurity NMT 0.10% | |
Total impurities NMT 0.5% | |
Related substances Ⅱ | PO-E NMT 0.10% |
PO-D1 NMT 0.10% | |
PO-R5 NMT 0.10% | |
Residual solvents | Methanol NMT 3000ppm |
Ethanol NMT 5000ppm | |
Dichloromethane NMT 600ppm | |
Tetrahydrofuran NMT 720ppm | |
N, N-dimethyl formamide NMT 880ppm | |
Triethylamine NMT 100ppm | |
Dimethy sulfoxide NMT 5000ppm | |
Water | NMT 2.0% |
Residue on ignition | NMT 0.1% |
Heavy metals | NMT 10ppm |
Microbial limit | Total aerobic NMT 1000cfu/g Total yeasts and molds NMT 100cfu/g E.coli should be absent |
Assay | 98.0%-102.0%(on anhydrous basis) |
98.0%-102.0%(on anhydrous and solvents free basis) |