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Empagliflozin is used in the treatment of 2 diabetic adults with diet combined with exercise who fail to achieve adequate glycemic control to improve glycemic control.
Empagliflozin mainly reduces plasma glucose levels by inhibiting the expression of SGLT-2, reducing renal glucose reabsorption and increasing the excretion of glucose in urine, and its hypoglycemic effect does not depend on β cell function and insulin resistance.
Items | Specifications | Results |
Appearance | White powder | |
Identification | HPLC. Retention time of main peak in Sample solution corresponds to that in reference solution,as obtained in test of isomer. | Complies |
IR.The IR spectrum is consistent with that obtained with the reference | Complies | |
Water | ≤0.5% | 0.07% |
Isomer | X0187-IMP06≤0.10% | 0.03% |
Residue on ignition | 0.06% | |
Related substances | X0187-IMP01≤0.10% | |
Not detected | ||
X0187-IMP04≤0.10% | <LOQ:0.04% | |
Any other individual impurity≤0.10% | 0.02% | |
Total impurities≤0.5% | 0.08% | |
Residual solvents | Toluene≤890ppm Tetrahydrofuran≤720ppm Acetonitrile≤410ppm Dichloromethane≤600ppm | 161ppm 75ppm Not detected Not detected |
Assay(on anhydrous basis) | 98.0%~102.0% | 99.5% |
Conclusion | The product conforms to the above specifications. | |
| Product parameters | |
| Cas number: | 864070-44-0 |
| Appearance: | White to off-white powder |
| Purity: | 99.5%min |
| Package details: | 100g/bottle; 1kg/bag |
| Brand: | Fortunachem |
Empagliflozin (sold under the brand name Jardiance, among others) is a prescription medication belonging to a class of drugs called SGLT2 inhibitors (Sodium-Glucose Co-Transporter 2 Inhibitors).
It works primarily in the kidneys. Normally, your kidneys reabsorb glucose back into the bloodstream. Empagliflozin blocks the SGLT2 protein, causing the kidneys to excrete excess glucose through urine. This effectively lowers blood sugar levels.
Empagliflozin is FDA-approved and widely used for several important conditions:
Primary Use: To improve glycemic (blood sugar) control in adults with type 2 diabetes, alongside diet and exercise.
Key Feature: Its action is insulin-independent, meaning it works regardless of the body's insulin production or resistance. It also carries a low risk of hypoglycemia (low blood sugar) when used alone.
Landmark Use: To reduce the risk of major cardiovascular events (e.g., heart attack, stroke) in adults with type 2 diabetes who have established cardiovascular disease.
This was a groundbreaking finding, showing empagliflozin provided significant heart protection.
For Heart Failure with Reduced Ejection Fraction (HFrEF): To reduce the risk of cardiovascular death and hospitalization for heart failure in adults (with or without type 2 diabetes).
For Heart Failure with Preserved Ejection Fraction (HFpEF): To reduce the risk of cardiovascular death and hospitalization for heart failure in adults.
To reduce the risk of sustained progression of kidney disease, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease (with or without type 2 diabetes).
Lowers Blood Sugar: Effectively reduces HbA1c levels.
Promotes Weight Loss: Excreting glucose means losing calories, leading to modest weight reduction.
Lowers Blood Pressure: Causes mild diuresis (fluid loss), which can help reduce blood pressure.
Cardio-Renal Protection: Its most significant benefits are protecting the heart and kidneys, making it a cornerstone therapy for patients with diabetes, heart failure, or CKD.
Common Side Effects:
Genital yeast infections (due to increased sugar in urine).
Urinary tract infections (UTIs).
Increased urination.
Possible dehydration, leading to dizziness or lightheadedness.
Serious Warnings (Black Box Warning):
Risk of Ketoacidosis: Rare but serious cases of euglycemic diabetic ketoacidosis (high ketones with normal or slightly high blood sugar) have occurred, sometimes in people with type 1 diabetes (for which it is not approved). Symptoms include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.
Other Serious Risks:
Necrotizing Fasciitis of the Perineum (Fournier's Gangrene): A rare, severe bacterial infection of the genital area.
Lower Limb Amputation: An increased risk was observed with a related drug (canagliflozin); risk with empagliflozin is less clear but remains a consideration.
Bone Fracture Risk: Potential increased risk.
Acute Kidney Injury: Risk is increased, especially with dehydration.
Usually taken once daily in the morning, with or without food.
Dosing depends on the condition being treated (e.g., 10 mg or 25 mg for diabetes, 10 mg for heart failure/CKD).
Crucial Disclaimer: This information is for educational purposes only. Empagliflozin is a potent medication that must be prescribed and managed by a qualified healthcare professional who can assess your individual health profile, risks, and benefits. Always consult your doctor for medical advice.




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