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Parameter
Limit
Appearance
:
White or almost white powder
Identification (By HPLC)
The retention time of the principal peak in the chromatogram of the sample solution corresponds to that in the obtained chromatogram of the standard solution.
Solubility
Slightly soluble in water and practically insoluble in methanol.
Assay (HPLC, on dry basis)
98 - 102 %
Unspecified Impurities (HPLC)
NMT 1.0 %
Total Impurities (HPLC)
NMT 3.0 %
Water Content
NMT 6.0 %
Specific Rotation (on dry basis)
- 19.00 to - 23.00