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Specifications
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Appearance: |
White to off-white powder |
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Melting point: |
72-80 °C |
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Optical rotation: |
+13° ~ +17° |
Identification
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Identity Test of UV: |
Spectral range: 200–400 nm; Absorption max: 224 nm; Weak max absorption: 277 nm |
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Identity Test of HPLC: |
Retention time of major peak should match standard solution |
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Purity: |
99.0% min |
Related substances
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Isomer: |
0.10% max |
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Unspecified impurities: |
0.10% max |
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Total impurity: |
1.0% max |
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Percentage of propanediol: |
13.6%–16.6% |
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Water: |
3.0%–4.4% |
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Residue on ignition: |
0.1% max |
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Heavy metals: |
20 ppm max |
Residual solvents
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Methanol: |
0.3% max |
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Ethanol: |
0.5% max |
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Acetonitrile: |
0.041% max |
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Dichloromethane: |
0.06% max |
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Ethyl acetate: |
0.5% max |
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n-Hexane: |
0.029% max |
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THF: |
0.072% max |
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Toluene: |
0.089% max |
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Assay: |
98.0%–102.0% of C21H25ClO6 (anhydrous, no propanediol) |
Transport Information
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Parameter |
Specification |
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UN Number |
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Class |
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Packing Group |
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H.S. Code |
2932999099304 |
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Stability & Reactivity |
The product is chemically stable under standard ambient conditions. |
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Storage |
Tightly closed. Store in a closed, dry, ventilated place |
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Condition to Avoid |
Strong oxidizing agents |
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Package |
Manufacturing Information
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Parameter |
Specification |
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Capacity |
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Frequency |
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Main Export Countries |
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Capacity/Batch |
100kg |
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Experience |
Production since 2009 |
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Stock |
In stock |
Overview
Dapagliflozin Propanediol丨CAS 960404-48-2 is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, used primarily in the treatment of type 2 diabetes mellitus. It is the propanediol solvate of dapagliflozin, which improves physical properties like solubility and stability without altering pharmacodynamics. Dapagliflozin lowers blood glucose levels by promoting glucose excretion in urine.
Applications
1. Treatment of Type 2 Diabetes Mellitus
Primary application is as an oral anti-diabetic agent.
Inhibits SGLT2 in the proximal renal tubules, reducing reabsorption of glucose and promoting urinary glucose excretion.
Effective as monotherapy or in combination with other drugs like metformin, insulin, or DPP-4 inhibitors.
2. Heart Failure and Chronic Kidney Disease (CKD)
Dapagliflozin has been shown to reduce the risk of cardiovascular death and hospitalization for heart failure, regardless of diabetes status.
Demonstrated renal protective effects, slowing progression of chronic kidney disease.
Approved for use in HFrEF (heart failure with reduced ejection fraction) and CKD patients.
3. Weight Loss and Blood Pressure Reduction
Provides modest weight loss due to caloric loss via glucosuria.
Exhibits mild diuretic effects, helping lower systolic and diastolic blood pressure.
Benefits
Effective glucose lowering without causing hypoglycemia (when used alone).
Reduces cardiovascular risk and provides renal protection.
Improves glycemic control, aids in weight loss, and helps in blood pressure management.
Favorable oral bioavailability and well-tolerated in long-term use.
Summary
Dapagliflozin Propanediol丨CAS 960404-48-2 is an advanced formulation of dapagliflozin used to manage type 2 diabetes, heart failure, and chronic kidney disease. As an SGLT2 inhibitor, it improves patient outcomes by lowering glucose levels, aiding weight loss, and offering cardioprotective and nephroprotective benefits. The propanediol solvate form ensures enhanced stability and bioavailability, making it a preferred choice in pharmaceutical development.
