Description

Canagliflozin Hemihydrate is a high-purity active pharmaceutical ingredient (API) and a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor. This compound is critical for the development and manufacture of innovative type 2 diabetes medications, offering a mechanism to lower blood glucose levels. It is primarily required by pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in metabolic disorder therapeutics.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of anti-diabetic drugs, specifically SGLT2 inhibitor class medications.
• Reference Standard: Used in analytical laboratories for quality control, method development, and validation in drug manufacturing.
• Biomedical Research: A key tool for in-vitro and in-vivo studies investigating SGLT2 inhibition, glucose metabolism, and related metabolic pathways.
• Drug Development: Serves as a critical starting material or intermediate in the synthesis of novel therapeutic agents targeting diabetes and related complications.
• Formulation Studies: Employed in pre-formulation and formulation research to develop stable and bioavailable dosage forms such as tablets.

Basic Information

Product Name	Canagliflozin Hemihydrate
CAS No.	928672-86-0
Molecular Formula	C24H25FO5S · ½ H2O
Molecular Weight	453.52 g/mol (hemihydrate)
Synonyms	Canagliflozin Hemihydrate; Canagliflozin Sesquihydrate; (1S)-1,5-Anhydro-1-C-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol Hemihydrate; JNJ 28431754; TA 7284; Invokana (Brand Name API); SGLT2 Inhibitor Canagliflozin
EINECS	Contact for details

Quality Control

Our Canagliflozin Hemihydrate is manufactured under strict quality systems. Each batch is tested to ensure compliance with high-purity standards suitable for pharmaceutical applications. A comprehensive Certificate of Analysis (COA) is provided, detailing results for identity, purity, assay, and specified impurities. We support compliance with ICH Q7 guidelines and relevant pharmacopeial standards.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	1.5% - 3.5%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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