Description

Dapagliflozin Propanediol Monohydrate is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) used in the synthesis of the SGLT2 inhibitor dapagliflozin. This compound is critical for ensuring the efficacy and safety of the final drug product, making reliable sourcing and stringent quality control paramount for manufacturers. It is primarily required by pharmaceutical companies and research institutions engaged in the development and production of innovative diabetes treatments.

Application

• Primary Pharmaceutical Ingredient: Key intermediate in the synthesis of the antidiabetic drug Dapagliflozin (Farxiga®/Forxiga®).
• Active Pharmaceutical Ingredient (API) Manufacturing: Serves as a critical building block for the final API under current Good Manufacturing Practice (cGMP) conditions.
• Research & Development: Used in preclinical and clinical studies for developing new SGLT2 inhibitor-based therapies.
• Process Development & Optimization: Employed in scaling up and refining synthetic routes for commercial production.
• Reference Standard: Acts as a high-purity standard for analytical method development and quality control testing.
• Formulation Studies: Utilized in the development of various drug delivery systems and dosage forms.

Basic Information

Product Name	Dapagliflozin Propanediol Monohydrate
CAS No.	960404-48-2
Molecular Formula	C21H25ClO6 • C3H8O2 • H2O
Molecular Weight	502.97 g/mol (for the monohydrate propanediol solvate)
Synonyms	Dapagliflozin (S)-Propylene Glycol Monohydrate; (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol compound with (2S)-Propane-1,2-diol monohydrate; BMS-512148 Propylene Glycol Solvate Monohydrate; Farxiga Intermediate; Forxiga Intermediate; SGLT2 Inhibitor Intermediate
EINECS	Contact for details

Quality Control

Our Dapagliflozin Propanediol Monohydrate is manufactured and tested to meet the stringent requirements for pharmaceutical intermediates. Quality is assured through a comprehensive analytical program including HPLC, NMR, and MS for identity and purity confirmation. We provide full traceability and support regulatory filings with detailed documentation. Certificates of Analysis (COA) are available upon request, detailing batch-specific results for all critical quality attributes.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.5%
Water Content (KF)	3.0% - 6.0%
Related Substances (HPLC)	Total impurities ≤1.5% Any single impurity ≤0.5%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤20 ppm

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