Description

Dapagliflozin CAS NO 461432-26-8 is a high-purity, selective sodium-glucose cotransporter 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 pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in the production of solid oral dosage forms.

Application

• Pharmaceutical API: Primary active ingredient in the commercial manufacture of SGLT2 inhibitor class anti-diabetic medications.
• Drug Formulation R&D: Used in the research and development of new tablet and capsule formulations for improved patient compliance and efficacy.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method validation in pharmaceutical laboratories.
• Clinical Trial Material: Essential for producing batches of investigational medicinal products (IMPs) for Phase I-III clinical studies.
• Combination Therapies: Utilized in the development of fixed-dose combination drugs for comprehensive diabetes management.
• Generic Drug Manufacturing: Key starting material for the production of bioequivalent generic versions post-patent expiry.

Basic Information

Product Name	Dapagliflozin
CAS No.	461432-26-8
Molecular Formula	C21H25ClO6
Molecular Weight	408.87 g/mol
Synonyms	Dapagliflozin; BMS-512148; (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol; Forxiga (Trade Name); Farxiga (Trade Name); SGLT2 Inhibitor BMS-512148; Dapagliflozin (anhydrous)
EINECS	Contact for details

Quality Control

Our Dapagliflozin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH Q7 guidelines for active pharmaceutical ingredients. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting results for assay, related substances, residual solvents, and other critical parameters.

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 in a dry environment 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 standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details

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