|
| Brand Name: | LIBANG |
| MOQ: | 15.0g |
| Price: | to be negotiated |
| Payment Terms: | T/T, L/C |
| Supply Ability: | 50 kg per year |
Melphalan Hydrochloride
| Melphalan | USP39 | |||||||||||||||||||
| BATCH NUMBER | C073-170615 | TEST DATE | 2017/06/15 | |||||||||||||||||
| BATCH SIZE | 150g | MANUFACTURING DATE | 2017/06/15 | |||||||||||||||||
| QUANTITY | 50G | RETEST DATE | 2020/06/14 | |||||||||||||||||
| TEST | SPECIFICATION | RESULT | ||||||||||||||||||
| Appearance | A white or off-white powder, crystalline powder | Conform | ||||||||||||||||||
| Identification | Identification A UV | UV spectrum corresponds to the UV spectrum of the reference standard | Conform | |||||||||||||||||
| Identification B | It gives reaction(a)of chlorides | Conform | ||||||||||||||||||
| Specific rotation | -30 and -36 | -31.23 | ||||||||||||||||||
| Loss on drying | NMT 7.0% | 3.93% | ||||||||||||||||||
| Residue on ignition | NMT 0.3% | 0.04% | ||||||||||||||||||
| Ionizable Chlorine | Not more than 1.0 ml of 0.1 N silver nitrate per 500 mg sample | 0.32 ml | ||||||||||||||||||
| Nitrogen content | 8.90%-9.45%(on the dried basis) | 9.12% | ||||||||||||||||||
| Related compounds |
Impurity D NMT3.0%
|
2.4% | ||||||||||||||||||
|
Impurity D NMT1.0%
|
0.67% | |||||||||||||||||||
|
Impurity D NMT0.5%
|
0.13% | |||||||||||||||||||
|
Impurity D NMT0.5%
|
0.10% | |||||||||||||||||||
|
Impurity D NMT0.3%
|
0.01% | |||||||||||||||||||
|
Impurity D NMT0.2%
|
0.04% | |||||||||||||||||||
| Unspecified Impurities: NMT0.1% | 0.06% | |||||||||||||||||||
|
Total impurity: NMT 5.5% NMT 1.0% |
3.61% | |||||||||||||||||||
| Residual solvents | Methanol | NMT 3000ppm | conform | |||||||||||||||||
| Assay |
93.0 %～100.5% (calculated on the dried and ionizable chlorine-free basis) |
98.56% | ||||||||||||||||||
| Packing and Storage: Preserve in tight, light-resistant containers. | ||||||||||||||||||||
| Conclusion: | All analythcal methods and results conform to the requirement of USP39 | |||||||||||||||||||
| Analysis | 孟庆华 | Checker | 张艳 | Supervisor | 孟庆华 | |||||||||||||||
