Description

Darunavir Impurity 10 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Darunavir. This compound is critical for ensuring the purity, safety, and efficacy of Darunavir-based drug products by serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments involved in the development and manufacturing of antiretroviral medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Darunavir API and finished dosage forms.
• Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating analytical methods, such as HPLC and UPLC.
• Quality Control and Batch Release: Used in routine QA/QC testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of forced degradation and long-term stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity profiling and control strategies to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the Darunavir synthesis pathway to minimize the formation of this specific impurity.

Basic Information

Product Name	Darunavir Impurity 10
CAS No.	1932330-83-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Darunavir Related Compound 10; Darunavir EP Impurity J; Darunavir USP Impurity 10; [(1R,5S,6R)-2,8-Dioxabicyclo[3.3.0]oct-6-yl] N-[(2S,3R)-4-[(4-aminophenyl)sulfonyl-(2-methylpropyl)amino]-3-hydroxy-1-phenylbutan-2-yl]carbamate; Prezista Impurity 10; TMC-114 Impurity 10
EINECS	Contact for details

Quality Control

Our Darunavir Impurity 10 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including HPLC purity, related substances, residual solvents, and spectroscopic identification (IR, NMR, MS). We support compliance with ICH guidelines and relevant pharmacopeial standards for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or in a desiccator after opening to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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