
Commodity: Ketoconazole Cas No.: 65277-42-1
MFG Date:2024.04.15Batch No:FH20240415
EXP Date :2028.04.15Quantity:500kg
| Specification | Results | |
| Characters | Almost white power | Almost white power | 
| Identification | Positive | Positive | 
| Appearance of solution | Solution S should be clear and not more intensely | Complies | 
| Solubility | Practically insoluble in water, freely soluble in methylene chloride, soluble in methanol, sparingly soluble in alcohol. | Complies | 
| Specific optical rotation | Between-0.10° and +0.10° | 0.001° | 
| Related substances | ≤0.5% | 0.16 % | 
| Heavy metals | ≤20ppm | < 20ppm | 
| Loss on drying | ≤0.5% | 0.06% | 
| Sulphated ash | ≤0.1% | 0.04% | 
| Assay | 99.0% ~ 101.0% | 99.9% | 
| Total Aerobic Microbial Count | ≤102cfu/g | Qualified | 
| Total Yeasts and Molds Count | ≤10'cfu/g | Qualified | 
| Pseudomonas aeruginosa | Absent per g | Qualified | 
| Staphylococcus aureus | Absent per g | Qualified | 
| Conclusion | The quality of the above commodity complies standard of BP/EP | |
| Packaging and storage | Preserve in well-closed containers, protected from light for 48 months. | |