Description

Nelfinavir Hydroxy-tert-Butylamide CAS NO 213135-56-9 is a key pharmaceutical intermediate, specifically a metabolite and synthetic precursor of the antiretroviral drug Nelfinavir Mesylate. This compound is critical for ensuring the quality, consistency, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers and advanced research institutions engaged in the development, scale-up, and quality control of HIV protease inhibitors.

Application

• Primary Pharmaceutical Intermediate: Used in the synthesis and purification of the antiretroviral drug Nelfinavir Mesylate.
• Reference Standard: Serves as a critical reference material in analytical laboratories for HPLC, LC-MS, and other chromatographic methods to quantify impurities and assay the API.
• Process Development & Validation: Essential for research and development (R&D) and process chemistry teams optimizing manufacturing routes for Nelfinavir.
• Metabolite Studies: Utilized in pharmacokinetic and metabolic pathway research to understand the drug's behavior in biological systems.
• Quality Control (QC) & Quality Assurance (QA): A vital component for establishing and maintaining stringent quality specifications for the final drug product.
• Regulatory Filings: Provides necessary data and substance for regulatory submissions (e.g., to FDA, EMA) requiring characterization of drug substances and related compounds.

Basic Information

Product Name	Nelfinavir Hydroxy-tert-Butylamide
CAS No.	213135-56-9
Molecular Formula	C32H45N3O4S
Molecular Weight	567.78 g/mol
Synonyms	AG-1350 Hydroxy-tert-Butylamide; Nelfinavir Impurity; Nelfinavir Related Compound; (3S,4aS,8aS)-N-tert-Butyl-2-[(2R,3R)-2-hydroxy-3-[(3-hydroxy-2-methylbenzoyl)amino]-4-(phenylthio)butyl]decahydroisoquinoline-3-carboxamide; Viracept Impurity; HIV Protease Inhibitor Intermediate
EINECS	Contact for details

Quality Control

Our Nelfinavir Hydroxy-tert-Butylamide is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the high standards required for pharmaceutical development and manufacturing. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting compliance with agreed specifications.

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 dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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