Description

Nelfinavir Related Compound A (15 mg) ((3S,4aS,8aS)-N-tert-Butyl-2-[(2R,3R)-2-hydroxy-3-(3-hydroxy-2-methylbenzamido)-4-(phenylsulfinyl)butyl]decahydroisoquinoline-3-carboxamide) is a high-purity reference standard critical for analytical and research applications. This compound is essential for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Nelfinavir, an antiretroviral medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The material is supplied as a precisely weighed 15 mg unit to guarantee convenience and accuracy in laboratory use.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material for the identification and quantification of specific impurities in Nelfinavir drug substance and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for quality control testing.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of related substances under various stress conditions to establish product shelf-life.
• Regulatory Compliance and Documentation: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity characterization.
• Pharmacological and Metabolic Research: Acts as a key intermediate or reference compound in studies investigating the metabolism and pharmacokinetics of Nelfinavir.
• Quality Assurance/Quality Control (QA/QC) Testing: Integral for routine batch release testing in pharmaceutical manufacturing to ensure compliance with pharmacopeial specifications (e.g., USP, EP).

Basic Information

Product Name	Nelfinavir Related Compound A (15 mg)
CAS No.	1041389-28-9
Molecular Formula	C33H47N3O6S
Molecular Weight	613.81 g/mol
Synonyms	(3S,4aS,8aS)-N-tert-Butyl-2-[(2R,3R)-2-hydroxy-3-(3-hydroxy-2-methylbenzamido)-4-(phenylsulfinyl)butyl]decahydroisoquinoline-3-carboxamide; Nelfinavir Impurity A; Nelfinavir Related Substance A; AG 1776 Related Compound A; Nelfinavir Sulfoxide Derivative; NFV Related Compound A; tert-Butyl (3S,4aS,8aS)-2-[(2R,3R)-2-hydroxy-3-(3-hydroxy-2-methylbenzamido)-4-(phenylsulfinyl)butyl]decahydroisoquinoline-3-carboxylate
EINECS	Contact for details

Quality Control

Every batch of Nelfinavir Related Compound A is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing batch-specific results for purity, assay, and related substances. Our quality commitment aligns with cGMP principles to support your regulatory and compliance needs.

Storage

Preserve in the original, tightly closed container, protected from all light exposure. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the desiccant is present and the container is kept sealed when not in use to prevent degradation. For long-term stability, storage at 2-8°C is recommended.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 98.5%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 1.5%
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.