Description

Darunavir Свz Amino Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the antiretroviral drug Darunavir. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final Active Pharmaceutical Ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific process-related impurities in Darunavir API.
• Analytical Method Development and Validation: Used as a critical standard to develop, validate, and verify HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control and Batch Release Testing: Essential for routine quality control testing of Darunavir drug substances and finished products to ensure compliance with ICH Q3A/B guidelines.
• Stability Studies and Degradation Pathway Analysis: Employed in forced degradation studies to understand the stability profile of Darunavir and to identify potential degradation products.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and control strategies.
• Research and Development: Used in synthetic chemistry research to study reaction pathways and optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Darunavir Свz Amino Impurity
CAS No.	159005-61-5
Molecular Formula	C27H37N3O7S
Molecular Weight	547.67 g/mol
Synonyms	Darunavir Carbobenzyloxy Amino Impurity; Darunavir Cbz-Amino Impurity; (3R,3aS,6aR)-Hexahydrofuro[2,3-b]furan-3-yl N-[(2S,3R)-4-[[(4-Aminophenyl)sulfonyl](2-methylpropyl)amino]-3-hydroxy-1-phenyl-2-butanyl]carbamate Cbz Derivative; TMC-126 Свz Amino Impurity; Darunavir Related Compound C; UNII-9V6M5N85CB (component); 1-Phenyl-2-[[(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-1-benzyloxycarbonylamino-2-hydroxypropyl]amino]butane Derivative.
EINECS	Contact for details

Quality Control

Our Darunavir Свz Amino Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets high-purity standards suitable for pharmaceutical reference use. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH and cGMP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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