Description

Doravirine CAS NO 1338225-97-0 is a potent and highly selective non-nucleoside reverse transcriptase inhibitor (NNRTI) used in antiretroviral therapy. It is a critical active pharmaceutical ingredient (API) for the treatment of HIV-1 infection, offering a favorable resistance profile and improved tolerability. This compound is essential for pharmaceutical manufacturers engaged in the development and production of next-generation antiviral medications.

Application

• Primary Active Pharmaceutical Ingredient (API) in the formulation of Doravirine tablets for HIV-1 treatment.
• Key component in fixed-dose combination (FDC) therapies for simplified HIV treatment regimens.
• Used in pharmaceutical research and development for novel antiretroviral drug candidates.
• Reference standard in analytical laboratories for quality control and method validation.
• Starting material or intermediate for the synthesis of more complex antiviral compounds.
• Supplied to contract manufacturing organizations (CMOs) and generic drug manufacturers.

Basic Information

Product Name	Doravirine
CAS No.	1338225-97-0
Molecular Formula	C₁₇H₁₅FN₆O
Molecular Weight	338.34 g/mol
Synonyms	MK-1439; Pifeltro (brand name); 4-[[4-[[4-[(E)-2-Cyanoethenyl]-2,6-dimethylphenyl]amino]pyrimidin-2-yl]amino]benzonitrile; (E)-3-(4-((4-(4-Cyanophenylamino)pyrimidin-2-yl)amino)-3,5-dimethylstyryl)acrylonitrile; Doravirine (USAN); UNII-1V3H2LZ85K
EINECS	Contact for details

Quality Control

Our Doravirine is manufactured under strict quality management systems. It undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and potency meet the stringent requirements for pharmaceutical use. Certificates of Analysis (COA) detailing all specifications are provided with each batch to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.