Description

Darunavir is a potent and selective non-peptidic protease inhibitor used in antiretroviral therapy. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of effective treatments against Human Immunodeficiency Virus (HIV-1) infection. It is essential for pharmaceutical manufacturers and research institutions developing and producing next-generation antiviral medications. Consistent quality and reliable supply are paramount for ensuring therapeutic efficacy and patient safety.

Application

• Pharmaceutical API: Primary use as the active ingredient in fixed-dose combination antiretroviral therapies (ART) for HIV-1 treatment.
• Antiviral Drug Formulation: Formulated into tablets, capsules, and oral suspensions for clinical use.
• Research & Development: Used in biochemical research to study HIV protease inhibition mechanisms and resistance profiles.
• Generic Drug Manufacturing: Serves as a key component for producers of generic antiretroviral medications.
• Preclinical & Clinical Studies: Employed in the development and testing of new therapeutic regimens and combination therapies.
• Reference Standard: Utilized as a high-purity analytical standard in quality control laboratories for drug testing and verification.

Basic Information

Product Name	Darunavir
CAS No.	206361-99-1
Molecular Formula	C₂₇H₃₇N₃O₇S
Molecular Weight	547.66 g/mol
Synonyms	Darunavir Ethanolate; TMC114; UIC-94017; (3R,3aS,6aR)-Hexahydrofuro[2,3-b]furan-3-yl (1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propylcarbamate; Prezista (Brand Name)
EINECS	Contact for details

Quality Control

Our Darunavir is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A detailed Certificate of Analysis (COA) providing results for assay, related substances, residual solvents, and other critical parameters is supplied with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C limits
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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