Standard

USP41-NF36

ITEMS

?

CRITERIA

Appearance

White?or?almost white, amorphous?or?crystalline powder. Freely soluble in water and in propylene glycol,?very slightly soluble in alcohol.

Identification

IR

Same absorption bands as USP Gamma Cyclodextrin RS.

HPLC

The retention time of the major peak of sample solution corresponds to the standard solution.

Optical rotation

+174°~+180°

Residue on Ignition

≤0.1%

Reducing Substances

≤0.5%

Alpha cyclodextrin

≤0.5%

Betadex cyclodextrin

≤0.5%

Sum of Other Impurities

≤0.5%

Loss on Drying

≤11.0%

Color and Clarity of Solution

At 420 nm, the absorbance is not greater than 0.20, and the solution is clear.

Assay

98.0%~102.0%

The total aerobic microbial count

≤1000cfu/g

The total combined moulds and yeasts count

≤100cfu/g

Packaging and storage

Preserve in well-closed containers?and store at room temperature.