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Empagliflozin API

Name of Product Empagliflozin API
CAS No 864070‑44‑0
Therapeutic use:- SGLT2 inhibitor for type 2 diabetes (also aids in heart failure and kidney protection)
Grade IH
Form:- API Powder
Status Commercial

Product Overview

Empagliflozin is a raw material active pharmaceutical ingredient for the manufacture of type 2 diabetes drugs.

Empagliflozin belongs to a category of drugs called SGLT2 inhibitors.

SGLT2 is the abbreviation for sodium-glucose co-transporter 2, which is a protein found in the kidneys.

The protein would otherwise draw sugar out of the urine and put it back into the blood.

By blocking the protein, Empagliflozin stops sugar from being reabsorbed.

The surplus sugar is eliminated from the body by the kidneys in urine form.

Empagliflozin’s official CAS number is 864070-44-0.

Clinical studies of empagliflozin-containing medicines have demonstrated benefits in reducing risk of heart failure and helping preserve kidney function in patients with type 2 diabetes.

The API appears as a white to off-white crystalline powder. 

Therapeutic Applications

  • Control of Blood Sugar: Reduces high blood sugar in type 2 diabetes.

  • Combination Products: Formulated with other APIs such as metformin or linagliptin to create fixed-dose medicines for better control.

  • Heart Health: Empagliflozin-containing drugs reduce the risk of heart failure in diabetic patients.

  • Kidney Protection: Exhibits reduction in the risk of kidney complications in long-standing diabetes.

  • Weight and Blood Pressure: Medicines based on the basis of this API can also help the patient lose excess weight and decrease blood pressure.

Specification Parameters

  • Appearance: White to off-white crystalline powder

  • Molecular Formula: C23H27ClO7

  • Molecular Weight: 450.91 g/mol

  • Solubility: Slightly soluble in water; freely soluble in methanol and ethanol

  • Melting Point: Around 153–155 °C

  • Identification Tests: Verified by IR spectroscopy, NMR, and HPLC

  • Assay (Purity): Not less than 99% on a dry basis

  • Loss on Drying: Shall meet pharmacopeial specifications, usually not more than 0.5%

  • Related Substances: Strictly controlled to avoid undesirable impurities

  • Microbial Limits: Shall clear safety assays for raw APIs

Packaging & Storage

Main Packaging Options:

  • Double-lined polyethylene bags for moisture protection

  • High-density polyethylene (HDPE) drums for stiffness

  • Fiber drums lined for further protection

Typical Pack Sizes:

  • 25 kg

  • 50 kg

  • Custom pack sizes as ordered

Storage Conditions:

  • Store in a dry, cool place

  • Avoid sun exposure and moisture

  • Storage temperature recommendation: less than 25 °C

  • Secure containers after use

Why Choose Us

Actiza Pharmaceutical Pvt. Ltd, is a specialist in supplying high-quality APIs with comprehensive regulatory support.

  • Products are USP, BP, and EP compliant, with DMFs available.

  • Industrial manufacturing units comply with cGMP protocols for clean and secure production.

  • Reliable supply chain servicing pharmaceutical partners globally.

  • Our packaging solutions are designed to ensure product stability and meet diverse client requirements.

  • Every batch is tested with state-of-the-art equipment like HPLC, IR, and NMR.

  • Our staff is dedicated to hassle-free service, quick response, and timely delivery.