GMP Certificated, month production 50MT.
Product Name: Fosfomycin sodium (nonsterile) EP6
ITEMS | STANDARD | RESULTS |
Characteristics | white hygroscopic powder | white hygroscopic powder |
Identification | positive | positive |
/p> | 9.0-10.5 | 10.3 |
Specific optical rotation | -13.0°-- -15.0° | -13.7° |
clear | Not more than 1# | Less than 1# |
Color | Not more than B9 | Less than B9 |
Water(%) | Not more than 1.0% | 0.9% |
1,2-Dihydroxylpropyl-snate | Not more than 1.0% | 0.6% |
Heavy metals | Not more than 20ppm | Less than 20ppm |
Assay(on the anhydrous basis) | 95.0%-101.0% | 96.3% |