|
Items |
Standard |
|
|
Appearance |
White or almost white, amorphous or crystalline powder. |
|
|
Solubility |
Freely soluble in water and in propylene glycol; practically insoluble in ethanol and in methylene chloride. |
|
|
Optical rotation |
+147°~+152° |
|
|
Identification |
Iodine test solution |
A yellow-brown precipitate is formed. |
|
HPLC |
The retention time of the major peak of sample solution corresponds to the standard solution. |
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|
pH |
5.0~8.0 |
|
|
Clarity and color of solution |
10mg/ml water solution is clear and colorless |
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|
Limit of Light-absorbing substances |
Between 230 and 350 nm the absorbance is NMT 0.10, and between 350 and 750 nm,the absorbance is NMT 0.05. |
|
|
Reducing sugars |
≤0.5% |
|
|
Related substance |
Betadex cyclodextrin |
≤0.25% |
|
Gamma cyclodextrin |
≤0.5% |
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|
Other related substances |
≤0.5% |
|
|
Loss on drying |
≤11.0% |
|
|
Residue on Ignition |
≤0.1% |
|
|
Heavy metal |
≤10ppm |
|
|
Assay(on the dried basis) |
98.0%~102.0% |
|
|
Microbial contamination |
TAMC |
≤1000cfu/g |
|
TYMC |
≤100cfu/g |
|
|
Escherichia coli |
Absence |
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