Description

Empagliflozin (R)-Isomer CAS NO 864070-43-9 is the pharmacologically active enantiomer of the SGLT2 inhibitor empagliflozin. This high-purity chiral intermediate is critical for ensuring the efficacy and safety of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers and advanced research institutions engaged in the development and production of innovative diabetes therapeutics.

Application

• Active Pharmaceutical Ingredient (API) Synthesis: Key chiral building block in the commercial and R&D-scale synthesis of the SGLT2 inhibitor Empagliflozin.
• Pharmaceutical Research & Development: Used in preclinical and clinical studies to investigate the specific pharmacological profile of the (R)-enantiomer.
• Process Chemistry & Optimization: Serves as a reference standard and starting material for developing and validating enantioselective synthetic routes.
• Analytical Method Development: Employed as a high-purity standard for HPLC, LC-MS, and chiral analysis to ensure product quality and regulatory compliance.
• Regulatory Filings: Essential material for generating the chemistry, manufacturing, and controls (CMC) data required for drug master files (DMF) and regulatory submissions (e.g., FDA, EMA).

Basic Information

Product Name	Empagliflozin (R)-Isomer
CAS No.	864070-43-9
Molecular Formula	C23H27ClO7
Molecular Weight	450.91 g/mol
Synonyms	(1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol; (R)-Empagliflozin; BI 10773 (R)-Isomer; (1S)-1,5-anhydro-1-[4-chloro-3-[[4-[[(3S)-oxolan-3-yl]oxy]phenyl]methyl]phenyl]-D-glucitol; SGLT2 Inhibitor (R)-Enantiomer
EINECS	Contact for details

Quality Control

Our Empagliflozin (R)-Isomer is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral purity verification by HPLC, to ensure it meets the stringent requirements for pharmaceutical intermediates. Certificates of Analysis (COA) detailing purity, enantiomeric excess, and impurity profiles are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥98.5%
Enantiomeric Purity (Chiral HPLC)	≥99.0%
Related Substances (HPLC)	Total impurities ≤1.0% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤0.5%

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