Identification A Ultraviolet absorption: absorptivity at 357nm is not
less than 95.0% not more than 105.0% 100.1%
Identification B
IR spectrum exhibits maxima only at the same
wavelengths as that of a similar preparation of the
reference standard.
Conforms
Identification C
The principal peak in theomatogram obtained with
the test solution is similar in retention time size to
the principal peak in theomatogram obtained with
the reference solution.
Conforms
Solubility Slightly soluble in water, soluble in acetone, in
methanol, in butyl acetate, in cyclohexanone Conforms
Crystallinity Meets the requirements Conforms
Microbe ≤100cfu/g Conforms
pH 6.0~7.5 6.28
Water ≤2.5% 0.1%
Residual
solvents
Acetone ≤5000ppm 340ppm
Methanol ≤3000ppm 850ppm
Ethyl ether ≤5000ppm 170ppm
Bacterial
endotoxins ≤10.0 IU/mg ≤0.07 IU/mg
Assay ≥970 μg/mg 986μg/mg