TESTS | SPECIFICATION | RESULTS |
Appearance | White or off-white powder | Conform |
Identification |
|
Conform |
|
Conform | |
Loss on drying | ≤5.0% | 3.0% |
PH Value | 5.0~8.0 | 5.90 |
Residue on ignition | ≤0.4% | 0.05% |
Water-soluble substances | ≤1.5% | 0.20% |
Heavy metals | ≤10ppm | <10ppm |
Peroxides | ≤400ppm | <400ppm |
Vinylpyrrolidone(HPLC) | ≤10ppm | 4.5ppm |
Nitrogen(on the anhydrous basis) | 11.0%~12.8% | 12.10% |
Particle size | 50~300um>80% | Conform |
Total aerobic plate count | ≤100CFU/g | <100CFU/g |
Mold/Yeast | ≤100CFU/g | <100CFU/g |
Staphylococcus Aureus | Negative | Negative |
Salmonella | Negative | Negative |
Pseudomonas aeruginosa | Negative | Negative |
E. Coli | Negative | Negative |
Conclusion: The Product Conforms to USP/EP. |