Product name | Sugammadex Sodium |
CAS No. | 343306-79-6 |
Molecular Formula | C72H104Na8O48S8 |
Molecular Weight | 2177.97 |
Quality Standard | 98% up |
Appearance | White powder
|
TEST | SPECIFICATION | RESULTS |
Appearance | White to off-white powder | White powder |
Identification | By chiral HPLC: the retention time of the main peak corresponds within 2.0% to that of the cis-(-)-EMTB reference standard | < 0.1% Conforms |
| By IR: Consistent with the reference standard | Conforms |
Clarity of solution (1% w/v in water) | Clear, essentially free of visible particles | Conforms |
Water Content | NMT 0.5% | < 0.1% |
Heavy Metals as lead | NMT 20 ppm | < 10 ppm |
Residue on ignition | NMT 0.2% | 0.1% |
Bulk density | Report data | 0.20 g/mL |
Particle size by laser light scattering | d50 ≤ 30 | 24 |
d90: 45~75 | 51 |
Residual solvent | Methanol ≤ 0.20% | ND |
Isopropyl acetate ≤ 0.20% | ND |
l-propanol ≤ 1.00% | 0.05 |
Any unspecified solvent ≤ 0.10 or ≤ the premitted daily exposure specified by ICH Q3C | ND |
EMTB-Dioxolane | ≤ 0.70% | ND |
EMTB-Carboxylic acid | ≤ 0.50% | ND |
EMTB-Disulfide | ≤ 0.30% | ND |
Emtb sulfoxides | ≤ 0.15% | 0.05% |
Any unspecified impurity by HPLC | ≤ 0.10% | Trace |
Total impurities by | ≤ 1.0% | 0.1% |
Assay by HPLC | 98.0~102.0 (Dried basis) | 100.1 |
98.0~102.0 (Anhydrous basis) | 100.1 |
Drug content factor(Report data) | 0.999 |
cis-(-)chiral purity by HPLC(%) | cis-(-)-EMTB ≥ 98.5 | 100.0 |
cis-(+)-EMTB (report data) | Trace |
trans-(-)-EMTB (report data) | ND |
trans-(+)-EMTB (report data) | ND |
CONCLUSION | LOT MEETS SPECIFICATION |
Sugammadex Sodium is the first and only selective relaxation binder, a major advancement in the field of muscle relaxants in the past 20 years. It allows the anesthesiologist to control the degree of muscle relaxation during the entire operation and increase the number of The quality of millions of operations represents the first major advancement in 20 years, making it possible to reverse surgical anesthesia.
Advantage of Sugammadex Sodium
1. The effect is remarkable and the effect is fast. The effect of antagonizing moderate and deep muscle relaxation can be quickly reversed, and the effect is complete. The average time from deep muscle relaxation to functional recovery is only 2-3 minutes.
2. Good tolerance and low incidence of adverse reactions. For some special populations, such as obese patients, elderly patients, children aged 2-17, patients with heart disease, patients with lung disease, and those with mild to moderate liver and kidney damage, no dose adjustment is required.
