Rifampicin is a broad-spectrum antibiotic drug with strong antibacterial effect on Mycobacterium tuberculosis, and also effective against Gram-positive or negative bacteria and viruses. It is a red or dark red crystalline powder, insoluble in water.| Items of Analysis | Specifications | Results |
| Characters | A red-brown crystalline powder; Very slightly soluble in water, freely soluble in chloroform, soluble in ethyl acetate/methanol. | A red-brown crystalline powder; Very slightly soluble in water, freely soluble in chloroform, soluble in ethyl acetate/methanol. |
| Identification | Infrared absorption spectrophotometry | Conforms |
| Crystallinity | Meets the requirements | Conforms |
| pH | 4.5-6.5 | 5.4 |
| Related substances | Rifampicin quinone<1.5% | 0.10% |
| Any other impurity<1.0% | 0.70% | |
| Sum of impurities<3.5% | 2.30% | |
| Loss on drying | <2.0% | 0.30% |
| Butanol<5000ppm | 2355ppm | |
| Residual Solvents | Aceton e<5000ppm | 59ppm |
| Dimethylformamide(DMF)<880ppm | Not detected | |
| Assay | 95.0%-103.0% | 99.40% |
| Bulk density | 0.73g/cm3 | |
| Conclusion:The product conforms to the USP 39 | ||








