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Specifications
| Appearance: | White to off-white powder |
| Purity (HPLC): | 99.0% min |
| Identification: | HPLC & IR |
| Melting Point: | 150°C to 155°C |
| Water: | 0.5% max |
| Residue on ignition: | 0.1% max |
| Heavy metal: | 20 ppm max |
| Related substances: | |
| - Impurity A: | 0.10% max |
| - Impurity C: | 0.10% max |
| - Total impurities: | 1.0% max |
| - Any unspecified impurity: | 0.10% max |
| Residual solvents (GC): | |
| - Dichloromethane: | 600 ppm max |
| - Ethyl acetate: | 5000 ppm max |
| - Ethanol: | 5000 ppm max |
| - Toluene: | 890 ppm max |
| - Methanol: | 3000 ppm max |
| - Isopropyl alcohol: | 5000 ppm max |
| - Tetrahydrofuran: | 720 ppm max |
| - n-Heptane: | 5000 ppm max |
| - Acetonitrile: | 410 ppm max |
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 |
2932190090303 |
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Stability & Reactivity |
The product is chemically stable under standard ambient conditions. |
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Storage |
Keep container tightly closed. Store in accordance with information listed on the product insert. |
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Condition to Avoid |
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Package |
Manufacturing Information
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Parameter |
Specification |
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Capacity |
1MT/month |
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Frequency |
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Main Export Countries |
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Capacity/Batch |
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Experience |
Production since 2010 |
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Stock |
Applications
1. Treatment of Type 2 Diabetes Mellitus
Monotherapy or combination therapy with other antidiabetic drugs (e.g., metformin, insulin).
Improves glycemic control by increasing urinary glucose excretion independent of insulin secretion.
2. Cardiovascular Risk Reduction
Empagliflozin is FDA- and EMA-approved for reducing the risk of cardiovascular death in adults with T2DM and established cardiovascular disease.
Shown to reduce hospitalization for heart failure (HF) in both diabetic and non-diabetic patients.
3. Chronic Heart Failure (HFrEF and HFpEF)
Used in treating heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF).
Reduces hospitalization rates and improves quality of life and functional outcomes in patients with HF.
4. Chronic Kidney Disease (CKD)
Empagliflozin has shown renal protective benefits, including slowing the progression of CKD and reducing proteinuria.
Helps maintain glomerular filtration rate (GFR) over time.
Benefits
✅ Improved Glycemic Control
Reduces HbA1c by ~0.6–0.9% as monotherapy or in combination.
Low risk of hypoglycemia when used without insulin or sulfonylureas.
✅ Cardiovascular Protection
Demonstrated significant reduction in cardiovascular death in the EMPA-REG OUTCOME trial.
✅ Weight Reduction
Causes modest weight loss (~2–3 kg), beneficial for overweight or obese patients with T2DM.
✅ Blood Pressure Reduction
Reduces systolic blood pressure (~4–5 mmHg) due to diuretic-like effect.
✅ Renal Protective Effects
Slows progression of diabetic nephropathy and reduces albuminuria.
✅ Once-daily Oral Administration
Improves patient adherence due to convenient dosing.
Conclusion
Empagliflozin (CAS 864070-44-0) is a highly effective SGLT2 inhibitor used not only to treat type 2 diabetes but also for cardiovascular and renal risk reduction. With proven mortality benefits, glycemic control, and protective effects on the heart and kidneys, it has become a cornerstone therapy in modern metabolic and cardiovascular medicine.
