ITEMS | SPECIFICATION |
Appearance | White, practically odorless, fine crystalline powder having a slightly sweet taste. Sparingly soluble in water |
Identification | IR | same absorption bands as USP Beta Cyclodextrin RS |
LC | the retention time of the major peak of sample solution corresponds to the standard solution |
Optical rotation | +160°~+164° |
Iodine test solution | A yellow-brown precipitate is formed |
Residue on Ignition | ≤ 0.1% |
Reducing Sugars | ≤ 0.2% |
Light-absorbing impurities | Between 230 nm and 350 nm,the absorbance is not greater than 0.10; and between 350 nm and 750 nm, the absorbance is not greater than 0.05 |
Alpha cyclodextrin | ≤0.25% |
Gamma cyclodextrin | ≤0.25% |
Other related substances | ≤0.5% |
Water determination | ≤14.0% |
Color and Clarity of Solution | A 10mg/ml solution is clear and Colorless |
pH | 5.0~8.0 |
Assay | 98.0%°~102.0% |
The total aerobic microbial count | ≤1000cfu/g |
The total combined moulds and yeasts count | ≤100cfu/g |