Nevirapine is a synthetic non-nucleoside reverse transcriptase inhibitor (NNRTI) and antiviral active pharmaceutical ingredient (API). It belongs to the dipyridodiazepinone class of compounds and selectively inhibits HIV-1 reverse transcriptase.
Nevirapine is used as an active pharmaceutical ingredient in antiretroviral formulations for the treatment of HIV-1 infection, generally in combination with other antiretroviral medicines. Official drug labeling identifies Nevirapine as an NNRTI with activity against HIV-1.
Nevirapine is an established antiretroviral pharmaceutical API used in pharmaceutical formulation development, HIV drug research, analytical testing and manufacture of antiretroviral medicines.
The API is available as anhydrous Nevirapine, while Nevirapine hemihydrate is also a recognized solid form. For CMS purposes, the actual form supplied should be matched with the product specification and CoA. PubChem identifies anhydrous Nevirapine under CAS 129618-40-2.
CAS Number: 129618-40-2
Molecular Formula: C₁₅H₁₄N₄O
Molecular Weight: 266.30 g/mol
Chemical Name: 11-Cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2′,3′-e][1,4]diazepin-6-one
IUPAC Name: 2-Cyclopropyl-7-methyl-2,4,9,15-tetrazatricyclo[9.4.0.0³,⁸]pentadeca-1(11),3,5,7,12,14-hexaen-10-one
Drug Class: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)
Therapeutic Class: Antiretroviral
Therapeutic Area: Infectious Diseases / HIV
Molecule Type: Synthetic Small Molecule
Development Code: BI-RG-587
PubChem reports the molecular formula C₁₅H₁₄N₄O, molecular weight 266.30 g/mol and CAS 129618-40-2.
Nevirapine is a non-competitive inhibitor of HIV-1 reverse transcriptase.
Its antiviral mechanism includes:
Nevirapine is selective for HIV-1 reverse transcriptase and belongs to the NNRTI class. Official labeling describes it as an antiretroviral drug with activity against HIV-1.
Nevirapine API is relevant to:
Nevirapine is used in combination with other antiretroviral medicines for management of HIV-1 infection.
Its mechanism differs from nucleoside/nucleotide reverse transcriptase inhibitors because it binds directly to a distinct allosteric site on HIV-1 reverse transcriptase.
Nevirapine is one of the established compounds in the NNRTI class. Its activity results from direct inhibition of HIV-1 reverse transcriptase rather than incorporation into viral DNA.
Research involving Nevirapine includes HIV reverse transcriptase inhibition, antiviral drug discovery and mechanisms of NNRTI resistance.
Nevirapine is described as a white to off-white, odorless to nearly odorless crystalline powder. Its molecular weight is 266.30 g/mol and its molecular formula is C₁₅H₁₄N₄O.
PubChem reports a topological polar surface area of 58.1 Ų and XLogP3-AA of approximately 2.0.
Nevirapine has limited aqueous solubility. Published physicochemical data report approximately 0.7 mg/L in water under specified conditions, while other references report approximately 100 mg/L at neutral pH. Because aqueous solubility varies significantly with pH and experimental conditions, the numerical value should not be treated as a universal pharmaceutical release specification.
Published references report different melting-point values for Nevirapine, including approximately 196°C and 247–249°C, depending on the source and material/form. Therefore, a single literature melting point should not be represented as an official API specification without matching the exact polymorphic/solid form.
A controlled Nevirapine API manufacturing process may involve:
Typical Nevirapine API testing may include:
Store Nevirapine API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.
Commercial storage conditions should be established according to validated stability data and the applicable API specification.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 1.0% |
| Melting Point | 196°C |