Description

Empagliflozin CAS NO 864070-44-0 is a potent and highly selective sodium-glucose co-transporter 2 (SGLT2) inhibitor. This active pharmaceutical ingredient (API) is critical for the development and manufacture of innovative type 2 diabetes mellitus (T2DM) therapeutics. It is primarily required by global pharmaceutical companies and contract development and manufacturing organizations (CDMOs) for the production of finished dosage forms.

Application

• Active Pharmaceutical Ingredient (API): Core component in the formulation of oral anti-diabetic medications.
• Pharmaceutical R&D: Used in preclinical and clinical research for developing new SGLT2 inhibitor-based therapies.
• Generic Drug Manufacturing: Serves as the key ingredient for producing generic versions of SGLT2 inhibitor drugs.
• Fixed-Dose Combination Drugs: Utilized in combination with other anti-diabetic agents like metformin for enhanced therapeutic effect.
• Cardiovascular Risk Reduction Medication: Incorporated into formulations indicated for T2DM patients with established cardiovascular disease.
• Reference Standard: Serves as a high-purity analytical standard for quality control and regulatory testing in laboratories.

Basic Information

Product Name	Empagliflozin
CAS No.	864070-44-0
Molecular Formula	C23H27ClO7
Molecular Weight	450.91 g/mol
Synonyms	Empagliflozin; BI 10773; (1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol; Jardiance (Brand Name); SGLT2 Inhibitor BI 10773; 1-(β-D-Glucopyranosyl)-4-methyl-3-[4-[(3S)-tetrahydrofuran-3-yloxy]benzyl]benzene
EINECS	Contact for details

Quality Control

Our Empagliflozin is manufactured under strict quality management systems. It undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and potency meet stringent pharmaceutical standards. A Certificate of Analysis (COA) detailing specifications and test results is provided with each batch to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 0.5%
Specific Rotation	Contact for details

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