| Product name | Chloramphenicol | Standard | BP2019 / EP9.0 |
| Batch No. | 20210302 | MFG. Date | MAR. 02, 2021 | Report Date | MAR. 03, 2021 |
| Batch size | 3000KGS | EXP. Date | MAR. 01, 2026 | Packing | 25kg/drum |
| Appearance | A while, greyish-white or yellowish-white, fine, crystalline powder or fine crystals, needles or elongated plates. | A yellowsh-white, fine
crystalline powder, needles
|
| Solubility | 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 range | 149°C ~153°C | 151~152°C |
| Infrared absorption spectrophotometry | IR spectrophotometry similar to which of Chloramphenicol CRS | Qualified |
| Acidity or alkalinity | To 0.1g add 20 ml of carbon dioxide-free water R, shake and add 0.1 ml of bromothymol blue solution Rl. Not more than0.1 ml of 0.02 M hydrochloric acid or 0. 02 M sodium hydroxide is required to
change the colour of the indicator. | Qualified |
| Specific optical rotation | +18.5°~20.5° | +19.8° |
| Related substances | Individaul impurity ≤ 0.5% | 0.31% |
| Chorides | ≤0.01% | <0.01% |
| Loss on drying | ≤0.3% | 0.18% |
| Sulfated ash | ≤0.1% | 0.06% |
| Assay | 98.0%~102.0% | 99.4% |
| Microbial limit | Total aerobic microbial count | ≤10CFU/g | <10CFU/g |
| Total yeasts and molds count | Absent per g | Absent |
| Escherichia coli | Absent per g | Absent |
| Pseudomonas aeruginosa & staphylococcus aureus | Absent per g | Absent |
| Conclusion | The product complies to BP2019 / EP9.0 |
| Packaging and storage | Preserve in well-closed containers, protected from light. |
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