ITEM | STANDARD | RESULTS |
Appearance | White or almost white crystalline granule and powder | A 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 |
Conforms |
Appearance of solution | ≤reference suspension II (1 mol/L hydrochloric acid) ≤reference suspension II (2 mol/L ammonia) |
≤Reference suspension I ≤Reference suspension I |
PH | 3.5~5.5 | 4.4 |
Specific optical rotation | +280~ +305 | +296 |
Related substances | Any impurity≤1.0% | 0.26% |
Dimethylaniline | ≤20ppm | Complies (not used in process) |
Water | 12.0%~15.0% | 13.3% |
Sulphated ash | ≤0.5% | 0.07% |
Bulk density | 0.45g/ml - 0.65g/ml | 0.57g/ml |
Tapped density | ≥0.65g/ml | 0.76g/ml |
Assay | 96.0%~102.0% C16H19N3O4S (calculated on the anhydrous basis) |
99.7% |