Description

Rac 8,14-Dihydroxy Efavirenz 8-o-β-D-Glucuronide is a key glucuronide metabolite of the antiretroviral drug Efavirenz, representing a critical reference standard for pharmaceutical research and development. This compound is essential for studying drug metabolism, pharmacokinetics, and the development of robust bioanalytical methods. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and academic institutions focused on antiviral drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the quantification and identification of Efavirenz metabolites in biological matrices during clinical and preclinical studies.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used to investigate the metabolic pathways, clearance mechanisms, and bioavailability of Efavirenz.
• Bioanalytical Method Development: Critical for developing and validating sensitive HPLC-MS/MS or LC-UV methods for therapeutic drug monitoring and pharmacokinetic profiling.
• Impurity Profiling and Characterization: Employed as a known impurity or degradation product to ensure the purity and stability of Efavirenz active pharmaceutical ingredient (API) batches.
• Regulatory Compliance and Submission: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive understanding of a drug's metabolic fate.
• Academic and Clinical Research: Supports fundamental research into HIV treatment efficacy, drug-drug interactions, and personalized medicine approaches.

Basic Information

Product Name	Rac 8,14-Dihydroxy Efavirenz 8-o-β-D-Glucuronide
CAS No.	1702668-56-1
Molecular Formula	C24H25F3NO10
Molecular Weight	544.46 g/mol
Synonyms	8,14-Dihydroxyefavirenz 8-O-β-D-glucuronide; Efavirenz 8-O-β-D-Glucuronide (8,14-dihydroxy); (8R,14S)-8,14-Dihydroxyefavirenz 8-O-β-D-glucuronide; (8S,14R)-8,14-Dihydroxyefavirenz 8-O-β-D-glucuronide; Rac-8,14-Dihydroxy-EFV 8-O-glucuronide; EFV Dihydroxy Glucuronide Metabolite; (±)-8,14-Dihydroxyefavirenz 8-O-β-D-glucopyranuronate
EINECS	Contact for details

Quality Control

Every batch of Rac 8,14-Dihydroxy Efavirenz 8-o-β-D-Glucuronide is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with research-grade standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive) and must be handled under dry conditions to ensure long-term stability. Allow the sealed vial to equilibrate to room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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