Description

Nelfinavir Mesylate CAS NO 159989-65-8 is the mesylate salt form of nelfinavir, a potent and selective inhibitor of the human immunodeficiency virus (HIV) protease. This active pharmaceutical ingredient (API) is critical for the formulation of antiretroviral medications used in combination therapy for HIV-1 infection. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of antiviral therapeutics.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of antiretroviral drugs for the treatment of HIV/AIDS.
• Antiviral Research: Serves as a key reference standard and biochemical tool in virology and pharmacology research for studying HIV protease inhibition.
• Drug Formulation Development: Used in the R&D of solid dosage forms (e.g., tablets) and other delivery systems for HIV therapy.
• Combinatorial Therapy: A component of Highly Active Antiretroviral Therapy (HAART) regimens, combined with other antiretroviral agents.
• Quality Control & Analytical Testing: Employed as a certified reference material in analytical laboratories for method validation and assay calibration.

Basic Information

Product Name	Nelfinavir Mesylate
CAS No.	159989-65-8
Molecular Formula	C32H45N3O4S • CH4O3S
Molecular Weight	663.88 g/mol
Synonyms	Nelfinavir Methanesulfonate; AG1343 Mesylate; Viracept (brand name mesylate salt); (3S,4aS,8aS)-N-tert-Butyl-2-[(2R,3R)-2-hydroxy-3-[(3-hydroxy-2-methylbenzoyl)amino]-4-(phenylthio)butyl]-decahydroisoquinoline-3-carboxamide methanesulfonate; HIV Protease Inhibitor AG1343 Mesylate
EINECS	Contact for details

Quality Control

Our Nelfinavir Mesylate is manufactured under strict quality systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical use. A comprehensive Certificate of Analysis (COA) is provided, detailing results for identity, purity, assay, and specified impurities. We support compliance with cGMP, ICH Q7 guidelines, and relevant pharmacopeial standards (e.g., USP, EP).

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 under conditions that minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.10%; Total impurities ≤ 1.0%
Specific Rotation	Contact for details

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