Description

Para-Hydroxy Elvitegravir (Elvitegravir M1) is a key pharmaceutical intermediate and metabolite of the antiretroviral drug Elvitegravir. This compound is of critical importance in the research, development, and quality control of HIV-1 integrase inhibitor therapies. It is primarily required by pharmaceutical R&D laboratories, analytical reference standard suppliers, and manufacturers engaged in the synthesis of active pharmaceutical ingredients (APIs) for antiviral medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantification and identification of Elvitegravir and its metabolites in biological matrices during pharmacokinetic studies.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Essential for studying the metabolic pathways, bioavailability, and excretion profiles of Elvitegravir in preclinical and clinical research.
• Impurity Profiling and Control: Serves as a specified impurity standard for quality control testing of Elvitegravir active pharmaceutical ingredient (API) batches to ensure compliance with ICH guidelines.
• Analytical Method Development: Employed in the development and validation of HPLC, LC-MS, and other chromatographic methods for drug analysis.
• Synthetic Intermediate: Utilized in advanced organic synthesis for the preparation of Elvitegravir and related chemical analogs in process chemistry.

Basic Information

Product Name	Para-Hydroxy Elvitegravir (Elvitegravir M1)
CAS No.	870648-10-5
Molecular Formula	C₂₃H₂₃ClFNO₅
Molecular Weight	447.88 g/mol
Synonyms	Elvitegravir Metabolite M1; Elvitegravir Hydroxy Metabolite; 6-(3-Chloro-2-fluorobenzyl)-1-[(2S)-1-hydroxy-3-methylbutan-2-yl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid; GS-9137 Metabolite; JTK-303 Metabolite; 4-Quinolinecarboxylic acid, 6-[(3-chloro-2-fluorophenyl)methyl]-1-[(2S)-1-hydroxy-3-methyl-2-butyl]-7-methoxy-4-oxo-
EINECS	Contact for details

Quality Control

Our Para-Hydroxy Elvitegravir is produced and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the stringent requirements for pharmaceutical reference standards and advanced intermediates. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

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

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