White or almost white crystalline granule and powder
Identification
(1) The spectrum obtained with the substance to be examined corresponds with that obtained with reference standard(2) Should meet the requirement under water
Appearance of solution
≤ reference suspension II (1 mol/L hydrochloric acid) ≤ reference suspension II (2 mol/L ammonia)
PH
3.5~5.5
Specific optical rotation
+280~ +305
Related substances
Any impurity≤ 1.0%
Dimethylaniline
≤ 20ppm
Water
12.0%~15.0%
Sulphated ash
≤ 0.5%
Bulk density
0.45g/ml - 0.65g/ml
Tapped density
≥ 0.65g/ml
Assay
96.0%~102.0% C16H19N3O4S (calculated on the anhydrous basis)