Description

Efavirenz Cyclobutene Impurity is a high-purity chemical reference standard used in the pharmaceutical development and manufacturing process. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Efavirenz, a key antiretroviral medication. It serves as an essential tool for analytical method development, validation, and routine quality control testing in pharmaceutical laboratories. Researchers and quality assurance professionals in the pharmaceutical and fine chemical industries rely on this standard to monitor and control impurities, ensuring compliance with stringent global regulatory requirements.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of the cyclobutene impurity in Efavirenz API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or GC-MS methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Efavirenz drug substances and products meet pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation impurities in Efavirenz formulations under various stress conditions.
• Process Chemistry Research: Aids chemists in optimizing synthesis pathways to minimize the formation of this specific impurity during Efavirenz manufacturing.
• Regulatory Submissions: Provides necessary data for impurity profiles in regulatory filings (e.g., FDA, EMA) for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).

Basic Information

Product Name	Efavirenz Cyclobutene Impurity
CAS No.	2177283-35-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Efavirenz Cyclobutene Related Compound; Efavirenz Impurity (Cyclobutene); Efavirenz Process Impurity; (4S)-6-Chloro-4-(2-cyclopropylethynyl)-4-(trifluoromethyl)-2,4-dihydro-1H-3,1-benzoxazin-2-one Cyclobutene Analog; Cyclobutene Derivative of Efavirenz; EFV Cyclobutene Impurity
EINECS	Contact for details

Quality Control

Every batch of Efavirenz Cyclobutene Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and consistency. Our quality commitment aligns with ICH Q7 and cGMP guidelines for pharmaceutical intermediates. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, related substances, residual solvents, and spectroscopic identification (NMR, MS).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle and store in accordance with good laboratory practices.

Specification

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

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