Dapagliflozin propanediol monohydrate

Dapagliflozin Propanediol Monohydrate (CAS 960404-48-2)

Dapagliflozin Propanediol Monohydrate (CAS 960404-48-2) is a crystalline co-form of Dapagliflozin, a prescription medication used to treat type 2 diabetes. It is formulated with (S)-propanediol and water in a 1:1:1 ratio. As a potent sodium-glucose cotransporter 2 (SGLT2) inhibitor, it plays a critical role in developing oral antidiabetic therapies including Dapagliflozin Propanediol (100 mg) tablets.

What Is Dapagliflozin Used For in Pharmaceutical Manufacturing?

Dapagliflozin is a medication used to treat type 2 diabetes. It is used together with proper diet and exercise to treat type 2 diabetes, reducing renal glucose reabsorption and improving glycemic control. The API supports cardiovascular and renal risk mitigation and is widely used in commercial formulations such as Farxiga and Xigduo XR.

What Are the Technical Specifications?

• Chemical Name: Dapagliflozin Propanediol Monohydrate
• Molecular Weight: ~502.99 g/mol
• CAS Number: 960404-48-2
• Appearance: White crystalline powder
• Purity: ≥99.5% (HPLC)
• Solubility: Soluble in DMSO, ethanol
• Storage: –20 °C, moisture-controlled conditions

Why Source Dapagliflozin Propanediol from Pharmint?

• GMP-certified supply chain with validated traceability
• USDMF, CEP, KDMF and CTD-format documentation available
• Bulk availability from 100 g R&D packs to 50+ kg commercial lots
• Analytical documentation including COA, MSDS, NMR, HPLC
• Support for ANDA and MA filings with end-use declaration

How Is It Packaged and Supplied?

• MOQ: 100 g (R&D) up to multi-kg commercial scale
• Packaging: LDPE/HDPE triple-layer containers with tamper-evident seal
• Shelf Life: ≥36 months with ICH stability data
• Shipping: Export-ready, includes MSDS, COA, and customs documents

What Quality and Compliance Standards Are Met?

• Produced under ICH Q7/Q11 GMP
• Full impurity profile and polymorph analysis
• USP/Ph. Eur/ICH-compliant test methods
• Audit-ready with QP documentation and TSE/BSE statements

Can It Be Used in Formulation Development?

Yes, Dapagliflozin Propanediol Monohydrate supports:

• Generic API-to-formulation projects
• Fixed-dose combinations with metformin, saxagliptin, etc.
• Chronic care, cardiovascular and renal co-indication therapies
• Submission-ready data for global DMF filings

How to Procure Dapagliflozin API in Bulk?

Pharmint offers seamless API sourcing with:

• A network of audited global manufacturers
• Regulatory and quality documentation for ANDA/MA submissions
• Logistics support including cold-chain, customs, and multilingual coordination
• Procurement support for EU, LATAM, MENA, and APAC markets

Dapagliflozin Propanediol FAQs 

Can I use Dapagliflozin Propanediol for fixed-dose combination (FDC) development?

Yes, Dapagliflozin Propanediol is commonly used in FDC formulations with metformin or saxagliptin for type 2 diabetes, supported by stability data and regulatory filings.

Does this API meet ICH Q11 expectations for development stage?

Dapagliflozin Propanediol meets ICH Q11 criteria with complete impurity profiling, process validation, and lifecycle management documentation for API control strategy.

Is a DMF available for Dapagliflozin Propanediol Monohydrate?

Yes, DMFs including USDMF, CEP, and KDMF are available from select GMP-qualified manufacturers and are aligned with CTD module 3 requirements.

How do I verify the polymorphic form of Dapagliflozin Propanediol?

The supplied API includes polymorph characterization via XRPD and DSC, ensuring the hydrate form aligns with reference listed drug (RLD) standards.

Does Pharmint offer audit support for this API supplier?

Yes, Pharmint coordinates GMP site audits or QP declarations and provides audit reports, quality agreements, and compliance history to facilitate qualification.