Address:
,China
Main Products:
native cyclodextrin,medicinals cyclodextrin,cyclodextrin derivatives,cyclodextrin complexes,cyclodextrin polymers
Specification :
ITEMS | SPECIFICATION(USP38) | RESULTS |
Appearance | white powder, insipid, innocent | Qualify |
Assay | ≥98% | 99.5% |
Degree of Substitution | 2.8-10.5 | 5.5 |
Clarity of solution | 50%(w/v) water solution is clear | clear |
Identification(IR) | same absorption bands with USP Hydroxypropyl Betadex RS | Qualify |
Loss on Drying | ≤10% | 4.5% |
Conductivity | 10%(w/v) water solution ≤200µS/cm |
70 |
Propylene oxide | ≤1ppm | <0.18ppm |
Propylene glycol | ≤2.5% | 0.05% |
Sum of Other Impurities | ≤1% | 0.51% |
Betadex | ≤1.5% | 0.39% |
Residue on Ignition | ≤0.2% | 0.09% |
Heavy Metal | ≤20ppm | <10ppm |
chloride | ≤0.05% | <0.05% |
Bacterial endotoxins | ≤25EU/g | <20EU/g |
TAMC(cfu/g) | ≤1000 | 80 |
TYMC(cfu/g) | ≤100 | 30 |
Salmonella/E. Coli (cfu/g) | Absent | Absent |
Storage: at room temperature, in tightly closed container.