Description
What is Nevirapine ?
Nevirapine is a non nucleoside reverse transcriptase inhibitor (Non-Nucleoside Reverse Transcriptase Inhibitor, NNRTI) of HIV-1. Nevirapine was directly linked to the reverse transcriptase of HIV-1 and blocked the RNA dependent and DNA dependent DNA polymerase activity by breaking the catalytic end of the enzyme.
Function and Application
Nevirapine could prevent mother to child transmission of H IV -1 in pregnant women who did not use antiretroviral therapy during childbirth. Nevirapine can be used alone to prevent mother to child transmission.
| Product Name | Nevirapine | ||
| Reference | USP | ||
| Test Items | Specifications | Results | |
| Characters | Description | White to off-white, odorless to nearly odorless, crystalline powder. | Off-white, odorless, crystalline powder |
| Solubility | Slightly soluble in alcohol and in methanol, practically insoluble in water. | Conform | |
| Identification | A: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. | Conform | |
| B: Infrared absorption spectrophotometry: corresponds to the reference standard. | Conform | ||
| Water(KF) | ≤0.2% | <0.1% | |
| Residue on ignition | ≤0.1% | <0.1% | |
| Heavy metals | ≤0.001% | <0.001% | |
| Related substances (HPLC) | **lmpurity A≤0.2% | N.D | |
| **lmpurity B≤0.2% | <LOQ(LOQ:0.04%) | ||
| **lmpurity C≤0.2% | <LOQ(LOQ:0.04%) | ||
| Any other individual unspecified impurity≤0.1% | 0.07% | ||
| Total impurities≤0.6% | 0.07% | ||
| Assay (HPLC) | 98.0 %~102.0 % (calculated on anhydrous basis) | 99.8% | |
| Residual solvents (GC) | Ethanol≤3000ppm | N.D | |
| Conclusion | Complies with USP | ||
