Dapagliflozin Specification Sheet: Key Details for API Procurement Teams
Dapagliflozin Specification Sheet: Key Details for API Procurement Teams
Last updated: 14 September 2026. Scope: the published Dapagliflozin identity and specification data on bio-synth.in, and the checks to run before release.
Dapagliflozin is an SGLT2 inhibitor API for type 2 diabetes. Bio-Synth supplies it as dapagliflozin propanediol monohydrate – molecular weight 502.98 g/mol, not the 408.87 of the free base. Get the form right on the purchase order first; everything on the certificate of analysis, water content included, follows from it.
Start With the Form
Most specification errors on this molecule start in the same place. Dapagliflozin API is supplied as the propanediol monohydrate – the free base with propylene glycol and water of crystallisation, 502.98 g/mol against the free base’s 408.87.
That is not academic. It changes the assay basis, the potency correction in your batch calculation, and the water limit you should expect. A sheet quoting 408.87 beside a monohydrate water limit has mixed two forms, and somebody downstream pays for it.
Identifiers and Published Limits
| Parameter | Detail |
|---|---|
| Product | Dapagliflozin Propanediol Monohydrate |
| CAS number | 461432-26-8 |
| Molecular formula | C21H25ClO6·C3H8O2·H2O |
| Molecular weight | 502.98 g/mol |
| Chemical name | (2S)-propane-1,2-diol (2S,3R,4R,5S,6R)-2-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-6-(hydroxymethyl)oxane-3,4,5-triol hydrate |
| Category | SGLT2 inhibitor |
| Therapeutic use | Type 2 diabetes |
| Form and colour | Powder, white to off-white |
| Total impurities | Not more than 1.0% |
| Single maximum unspecified impurity | Not more than 0.1% |
| Loss on drying | Not more than 1.0% w/w |
| Water content by Karl Fischer | 2.5%–4.5% w/w |
| Solubility | Soluble in N,N-dimethylformamide, dimethyl sulfoxide and ethanol; insoluble in water and cyclohexane |
| Pack size | As per requirement |
The water band is the giveaway: a monohydrate carries stoichiometric water, so 2.5–4.5% by Karl Fischer is what you expect. Anything quoting “not more than 1.0%” water is describing a different form.
What to Check on the Certificate
- Form and assay basis together. Anhydrous, as-is, and dried basis are three different numbers.
- Chiral purity, with the control strategy for each stereocentre.
- Residual solvents against ICH Q3C, elemental impurities under ICH Q3D.
- Related substances split into specified and unspecified.
- Water by Karl Fischer read against the monohydrate range.
Dapagliflozin API quality parameters take these test by test; how Dapagliflozin API is manufactured explains where the impurities come from.
Certification, Read Properly
A GMP certificate is issued against a named schedule of products, so ask which products sit on the schedule attached to the current one. Bio-Synth manufactures at a licensed Balanagar site in Hyderabad under the Drugs and Cosmetics Act, 1940, working to ICH Q7 principles, with an ISO 9001:2015 certified quality management system – see the quality systems page.
FAQs
What is the CAS number of Dapagliflozin API?
461432-26-8, as published on the product page.
What is the molecular weight of Dapagliflozin?
502.98 g/mol for the propanediol monohydrate supplied; 408.87 g/mol for the free base. Quote the form alongside the number.
Why is the water limit 2.5–4.5% rather than 1.0%?
The monohydrate carries stoichiometric water. A 1.0% ceiling belongs to a different form.
Dapagliflozin or Empagliflozin?
Dapagliflozin vs Empagliflozin sets the two SGLT2 inhibitors side by side.
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