Beta cyclodextrin
Test items |
Specifications |
Results |
|
Appearance |
White practically odorless,fine crystalline powder having a slightly sweet taste,Sparingly soluble in water |
Conform |
|
Identification |
|
|
|
IR |
Same absorption bands as USP Bera Cyclodextrin RS |
Conform |
|
LC |
The retention time of the major peak of sample solution corresponds to the standard solution |
Conform |
|
Optical rotation |
+160°~+164° |
+163° |
|
Iodine test solution |
A yellow-brown precipitate is formed |
Conform |
|
Residue on Ignition |
≤0.1% |
Conform |
|
Reducing Sugars |
≤0.2% |
Conform |
|
Light-absorbing impurities |
Between 230nm and 350nm,the absorbance is not greater than 0.10;and between 350nm and 750nm,the absorbance is not greater than 0.05. |
Conform |
|
Alpha cyclodextrin |
≤0.25% |
Conform |
|
Gamma cyclodextrin |
≤0.25% |
Conform |
|
Other related substances |
≤0.5% |
Conform |
|
Water determination |
≤14.0% |
11.4% |
|
Color and Clarity of solution |
0.2g/20ml water solution is clear and colorless |
Conform |
|
pH |
5.0-8.0 |
5.8 |
|
Assay |
98.0-102.0% |
99.6% |
|
The total aerobic mirobial count |
≤1000cfu/g |
50cfu/g |
|
The total combined moulds and yeasts count |
≤100cfu/g |
<10cfu/g |
|
Packaging and storage |
Preserve in tight containers.No storage requirements specified |
||
Conclusion |
The product complies with USP43-NF38 |