Description

Remogliflozin A is a high-purity pharmaceutical intermediate and reference standard of significant importance in modern drug development. Its core value lies in its role as a key synthetic precursor for the development of SGLT2 (Sodium-Glucose Cotransporter-2) inhibitor class drugs, which are critical for managing type 2 diabetes. This compound is essential for pharmaceutical R&D laboratories, analytical testing facilities, and manufacturers engaged in the production of novel anti-diabetic therapeutics and related metabolic disorder treatments.

Application

• Pharmaceutical Intermediate: Primary use as a critical building block in the synthesis of SGLT2 inhibitor active pharmaceutical ingredients (APIs).
• Reference Standard: Serves as a certified standard for analytical method development, validation, and quality control (QC) testing in pharmaceutical manufacturing.
• Research & Development: Used in preclinical and clinical research to study the pharmacokinetics, metabolism, and efficacy of novel anti-diabetic compounds.
• Process Chemistry: Employed in scaling up and optimizing synthetic routes for the cost-effective production of SGLT2 inhibitors.
• Impurity Profiling: Acts as a marker or related substance standard for identifying and quantifying process-related impurities and degradation products.
• Regulatory Submissions: Provides essential material for generating data packages required for regulatory filings with agencies like the FDA and EMA.

Basic Information

Product Name	Remogliflozin A
CAS No.	329045-45-6
Molecular Formula	C23H30ClNO6S
Molecular Weight	484.01 g/mol
Synonyms	Remogliflozin Etabonate Impurity A; 1-(4-Ethoxybenzyl)-3-[(5S)-5-(4-fluorophenyl)-5-hydroxy-1,2,3,4-tetrahydroisoquinolin-6-yl]sulfonylurea; BTS 67 582 Impurity A; GSK-189075 Impurity A; SGLT2 Inhibitor Intermediate; 1-(4-Ethoxybenzyl)-3-[(5S)-5-(4-fluorophenyl)-5-hydroxy-3,4-dihydro-1H-isoquinoline-6-sulfonyl]urea
EINECS	Contact for details

Quality Control

Our Remogliflozin A is manufactured under strict quality management systems to ensure batch-to-batch consistency and high purity. Each lot is subjected to comprehensive analytical testing, including HPLC for assay and impurity profiling, and is supplied with a corresponding Certificate of Analysis (COA). We support compliance with cGMP (current Good Manufacturing Practice) and ICH (International Council for Harmonisation) guidelines for pharmaceutical intermediates, ensuring suitability for use in regulated environments.

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 stability, storage under inert atmosphere (e.g., nitrogen) is recommended. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
Heavy Metals	≤ 20 ppm

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