Description

Darunavir Impurity 13 is a specified impurity and degradation product of the antiretroviral drug Darunavir. This compound is critical for pharmaceutical research and development, serving as a reference standard for quality control and regulatory compliance. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry for method development, validation, and ensuring the purity and safety of Darunavir drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Darunavir active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance: Critical for routine batch testing in pharmaceutical manufacturing to ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of Darunavir.

Basic Information

Product Name	Darunavir Impurity 13
CAS No.	156636-67-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Darunavir Related Compound 13; Darunavir Impurity K; [(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; TMC-126 Impurity; Prezista Impurity 13
EINECS	Contact for details

Quality Control

Our Darunavir Impurity 13 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure high purity and identity confirmation, aligning with current industry standards for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for purity (by HPLC), identification (by IR and/or MS), and other relevant tests.

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 dry conditions to prevent degradation. For long-term storage, consider storing under an 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)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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