ITEMS
Standard
Results
Appearance
White to almost white powder
Conform
Identification
TLC Identification
The test solution is similar in position, colour to the principal spot in the chromatogram obtained with reference solution.
HPLC Identification
The retention time of major peak obtained from the sample solution should be consistent with that obtained from standard solution.
Sulfate Ident.
Present the identification of sulfate.
PH
6.0-8.0
7.5
Water
≤2.0%
1.3%
Heavy metals
≤30ppm
Residue on ignition
≤1.0%
0.13%
Chromatographic purity
Bacterial endotoxins
≤2.0EU/mg
Residual Solvents(ethanol)
≤5000ppm
27ppm
Assay(on the anhydrous basis)
634-739 µg/mg
710µg/mg
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