Description

Darunavir Impurity 7 (S,S-Isomer) is a high-purity stereoisomeric impurity used as a critical reference standard in the development and quality control of the antiretroviral drug Darunavir. This compound is essential for ensuring the safety and efficacy of the active pharmaceutical ingredient by enabling the accurate identification, quantification, and control of its related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of the (S,S)-isomer impurity in Darunavir active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling and assay determination.
• Quality Control & Batch Release Testing: A critical component in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) to establish shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Used in process chemistry R&D to understand and minimize the formation of this isomer during the synthesis and purification of Darunavir.

Basic Information

Product Name	Darunavir Impurity 7 (S,S-Isomer)
CAS No.	192800-79-6
Molecular Formula	C27H37N3O7S
Molecular Weight	547.67 g/mol
Synonyms	[(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester (S,S-Isomer); Darunavir Related Compound S,S-Isomer; (S,S)-Diastereomer of Darunavir Impurity 7; TMC-126 Impurity S,S; Darunavir EP Impurity G (S,S); Darunavir USP Related Compound S,S; [(1S,2R)-3-[[(4-Aminophenyl)sulfonyl](isobutyl)amino]-2-hydroxy-1-benzylpropyl]carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Each batch of Darunavir Impurity 7 (S,S-Isomer) is characterized and qualified using advanced analytical techniques to meet the exacting requirements for pharmaceutical reference standards. Certificates of Analysis (COA) are provided, detailing comprehensive analytical results including purity by HPLC, identity confirmation (IR, MS, NMR), and impurity profile. Our quality system is designed to support compliance with cGMP and relevant pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%

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