Molecular Formula | C42H70O35 |
---|---|
Formula Weight | 1135.0 |
Possible impurities | Other cyclodextrins, linear oligomers |
Solubility (in 100 cm3 solvent, at 25 °C) |
Water: < 2.0 g Methanol: < 1.0 g DMSO: > 10 g |
Test | Method | Range |
---|---|---|
Appearance | Visual | white or almost white powder |
Identification A: Specific optical rotation | EP 2.2.7 | +160° to +164° |
Identification B: HPLC | EP 2.2.29 | conforms with reference |
Identification C: Iodine test | yellow-brown precipitate | |
Appearance of 1% aqueous solution | Visual (EP 2.2.1) | clear and colorless solution |
pH of 1% aqueous solution | EP 2.2.3 | 5.0 - 8.0 |
Reducing sugars | max. 0.2% | |
Light absorbing impurities (1%) | UV-Vis (EP 2.2.25) | A230 - A350: max. 0.10 A350 - A750: max. 0.05 |
Related substances residual ACD residual GCD sum of other impurities |
HPLC (EP 2.2.29) | max. 0.25% max. 0.25% max. 0.50% |
Residual solvents | GC (EP 2.2.28) | max. 10 ppm trichloroethylene max. 10 ppm toluene |
Heavy metals | EP 2.4.20 | Cd max. 0.2 ppm Pb max. 0.5 ppm As max. 1.5 ppm Hg max. 0.3 ppm Co max. 0.5 ppm V max. 1 ppm Ni max. 2 ppm |
Sulphated ash | EP 2.4.14 | max. 0.1% |
BCD content | HPLC (EP 2.2.29) | 98.0 - 101.0% |
Microbial contamination | EP 2.6.12, EP 2.6.13 | TAMC: <103 CFU/g TYMC: <102 CFU/g Salmonella: absent/10 g E. Coli: absent/1 g |
Loss on drying | EP 2.2.32 | max. 16.0% |