Description

Canagliflozin α Isomer is a specific stereoisomeric form of the active pharmaceutical ingredient Canagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor. This high-purity isomer is critical for pharmaceutical research and development, particularly in the synthesis and characterization of novel therapeutic agents targeting type 2 diabetes and related metabolic disorders. It serves as a vital reference standard and building block for analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in metabolic disease drug discovery and quality control.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification, assay, and impurity profiling of Canagliflozin in analytical method development and validation (HPLC, LC-MS).
• Active Pharmaceutical Ingredient (API) Intermediate: Serves as a key chiral synthon in the sophisticated multi-step synthesis of the final Canagliflozin API, ensuring correct stereochemistry.
• Metabolic Disease Research: Employed in preclinical and clinical research to study the specific pharmacological activity, pharmacokinetics, and metabolic pathways of the α-isomer.
• Process Chemistry & Optimization: Utilized in pharmaceutical process development to optimize yield, purity, and stereoselectivity during API manufacturing.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed characterization of all isomeric components in a drug substance.
• Quality Control Laboratories: Acts as a critical comparator in in-house quality testing to confirm the identity and isomeric purity of bulk drug substances and finished dosage forms.

Basic Information

Product Name	Canagliflozin α Isomer
CAS No.	1589590-87-3
Molecular Formula	C24H25FO5S
Molecular Weight	444.52 g/mol
Synonyms	Canagliflozin alpha isomer; (1S)-1,5-Anhydro-1-C-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol; (1S)-1,5-anhydro-1-C-[3-[[5-(4-fluorophenyl)thiophen-2-yl]methyl]-4-methylphenyl]-D-glucitol; Canagliflozin Isomer A; SGLT2 Inhibitor α-Isomer; JNJ 28431754 alpha isomer; Invokana α-isomer
EINECS	Contact for details

Quality Control

Our Canagliflozin α Isomer is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and strength, meeting the stringent requirements for pharmaceutical reference standards and intermediates. Specifications typically align with pharmacopeial standards for chiral purity and organic impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting results for assay, chiral purity, related substances, residual solvents, and other critical quality attributes.

Storage

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

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)	≥98.0%
Chiral Purity (Chiral HPLC)	≥99.0%
Related Substances (HPLC)	Individual impurity: ≤0.5% Total impurities: ≤1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤0.5%

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