ITEM | STANDARD | RESULTS |
Appearance | White or off-white powder | Conformed |
Identification | Meets the requirements | Conformed |
pH | 7.3-8.3 | 8.07 |
Loss on drying | 9.0%~12.0% | 10.2% |
Chromatographic RRT(0.45) |
0.80% MAX | 0.13% |
Purity RRT(1.90) |
0.60% MAX | 0.15% |
Particulate matter ≥10 um ≥25 um |
≤6000 pc/g ≤600 pc/g |
Conformed Conformed |
Uniformity of dosage unites | Meets the requirements | Conformed |
Bacterial endotoxinsunder | ≤0.125EU/mg | Conformed |
Sterility | Sterility | Conformed |
Content of sodium | 5.3%-8.0% | 6.8% |
Assay(C17H25N3O5S) on anhydrous basis | ≥ 76.0% | 80.7% |
Conclusion | The product conforms the USP30 standard |