| Product name | Chloramphenicol | |
| Shelf Life | 1 year | |
| Items | Standard | Result |
| Characters | A white, greyish-white or yellowish-white,fine,crystalline powder or fine | A yellowish-white,fine crystalline powder |
| Slightly soluble in water,freely soluble in alcohol and in propylene glycol. Its alcohol solution is dextrorotatory and its ethyl acetate solution is levorotatory | Qualified | |
| Identification | Melting point: 149°C〜153°C | 149 C-152°C |
| 1R | Qualified | |
| TLC | ||
| Colar reaction | ||
| Gives reaction of chlorides | ||
| Acidity or alkalinity | Meets the requirements | Qualified |
| Specific optical rotation | + 18.5° 〜+20_5o | + 19.8° |
| Related Substances | Individual impurity<0. 5% | Qualified |
| Chlorides | < 0. 01% | Qualified |
| Loss on drying | < 0. 5% | 0.10% |
| Sulphated ash | < 0. 1% | 0.04% |
| Assay | 98.0% 〜102.0% | 99.7% |
| Microbial limit | Bacteria Not more than 10 per g | Qualified |
| Mold & yeast Absent per g | ||
| Escherichia coli Absent per g | ||
| Pseudomonas aeruginosa & staphylococcus aureus Absent per g | ||
| Sterility | Complies | Qualified |
| CONCLUSION: The product complies to the standard of BP2011. | ||