Description

Darunavir Impurity 19 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Darunavir, a key antiretroviral medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing. The use of this well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines (e.g., USP, ICH) governing impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Darunavir API and its formulated drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring product consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Research & Development: Facilitates process chemistry research aimed at minimizing impurity formation during the synthesis of Darunavir.

Basic Information

Item	Detail
Product Name	Darunavir Impurity 19
CAS No.	1402142-62-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Darunavir Related Compound 19; Darunavir EP Impurity J; Darunavir USP Impurity; Prezista Impurity 19; (3R,3aS,6aR)-Hexahydrofuro[2,3-b]furan-3-yl N-[(2S,3R)-4-[(4-aminophenyl)sulfonyl-(2-methylpropyl)amino]-3-hydroxy-1-phenylbutan-2-yl]carbamate; TMC-114 Impurity 19
EINECS	Contact for details

Quality Control

Every batch of Darunavir Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (e.g., HPLC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and the container kept sealed when not in use to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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