| Product Name: Cisatracurium besylate |
| Cas No.:96946-42-8 |
| Molecular Formula:C 6 5 H 8 2 N 2 O 1 8 S 2 |
| Molecular Weight:1243.48 |
|
Appearance: White or off-white crystalline powder
Assay (HPLC): 95-102% Acidity: 3.5-5.0 Specific optical rotation: -48°~ -58° Sulfates: 0.05%max Related substances: Narrow isomer: 0.5%max Cis-and trans-isomers: 0.5%max Unknown monomer: 1.5%max Total impurities: 5.0%max Residue on ignition: 0.2%max Loss on drying: 2.0%max Heavy metals: < 20ppm Package: 25kg/fibre drum Certification: DMF OPEN PART, ISO9001:2008, ISO14001:2004 |
|
Analysis Test |
Specification |
Result |
|
Description |
white crystalline powder,odorless |
Conforms |
|
Solubility |
Easily soluble in water, unsoluble in ethanol |
Conforms |
|
PH |
6.0~7.5 |
6.9 |
|
Solution clarity and color |
solution should be clear and colorless |
Conforms |
|
Related substances |
5'CMP 0.3% Simple impurity Total other impurity |
0.01% 0.03% 0.10% |
|
Chloride |
0.05% |
Conforms |
|
Ammonium |
0.05% |
Conforms |
|
Fe |
0.01% |
Conforms |
|
Phosphate |
0.1% |
Conforms |
|
Loss on drying |
≤6.0% |
1.3% |
|
Heavy metals |
0.002% |
Conforms |
|
Arsenide |
0.0001% |
Conforms |
|
Bacterial Endotoxins |
0.3EU/mg |
Conforms |
|
Microbial Limit |
Conforms |
Conforms |
|
Assay(on dried basis) |
≥98.0% |
98.8% |