Description

Efavirenz Impurity 15 (8,14-Dihydroxy Efavirenz) is a specified impurity and degradation product of the antiretroviral drug Efavirenz. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Efavirenz-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Efavirenz Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor degradation pathways.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopoeial limits (e.g., ICH Q3B).
• Stability Studies: Used to profile and quantify degradation products formed under various stress conditions (e.g., hydrolysis, oxidation, photolysis).
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding the synthesis and degradation pathways of Efavirenz, helping to optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Efavirenz Impurity 15 (8,14-Dihydroxy Efavirenz)
CAS No.	252343-27-4
Molecular Formula	C14H9ClF3NO4
Molecular Weight	347.67 g/mol
Synonyms	8,14-Dihydroxy Efavirenz; Efavirenz 8,14-Dihydroxy Impurity; Efavirenz Related Compound 15; (4S)-6-Chloro-4-(2-cyclopropylethynyl)-1,4-dihydro-8,14-dihydroxy-4-(trifluoromethyl)-2H,3H-benzo[1,2-b:3,4-b']dipyran-2-one; 2H,3H-Benzo[1,2-b:3,4-b']dipyran-2-one, 6-chloro-4-(2-cyclopropylethynyl)-1,4-dihydro-8,14-dihydroxy-4-(trifluoromethyl)-, (4S)-; Efavirenz Dihydroxy Impurity.
EINECS	Contact for details

Quality Control

Our Efavirenz Impurity 15 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 the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each product, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
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.