Description

Efavirenz Impurity 13 (7-Hydroxy Efavirenz) is a key pharmaceutical reference standard and impurity used in the research, development, and quality control of the antiretroviral drug Efavirenz. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and validation of HIV/AIDS therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for calibrating analytical instruments and validating testing methods in QC/QA laboratories.
• Impurity Profiling and Control: Used for the identification, characterization, and quantification of 7-Hydroxy Efavirenz as a specified impurity in Efavirenz Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor degradation products.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Efavirenz.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Used in metabolic and pharmacokinetic studies to understand the drug's behavior in biological systems.

Basic Information

Item	Detail
Product Name	Efavirenz Impurity 13 (7-Hydroxy Efavirenz)
CAS No.	252343-24-1
Molecular Formula	C14H9ClF3NO3
Molecular Weight	331.67 g/mol
Synonyms	7-Hydroxyefavirenz; (4S)-6-Chloro-4-(2-cyclopropylethynyl)-4-(trifluoromethyl)-2,4-dihydro-1H-3,1-benzoxazin-2-one 7-ol; Efavirenz Related Compound C; Efavirenz Hydroxy Impurity; Efavirenz Metabolite; 7-OH Efavirenz; Benzoxazinone derivative
EINECS	Contact for details

Quality Control

Every batch of Efavirenz Impurity 13 (7-Hydroxy Efavirenz) is manufactured and analyzed under strict quality management systems. The product is characterized using advanced spectroscopic and chromatographic techniques to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and other critical parameters. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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