
Chemical Name:Eptifibatide Acetate
CAS:148031-34-9
Molecular Formula:C<sub>35</sub>H<sub>49</sub>N<sub>11</sub>O<sub>9</sub>S<sub>2</sub>
Molecular Weight:831.96 g/mol
Appearance:White to off-white powder
Solubility:Soluble in water
Storage Conditions:Store at 2°C to 8°C (36°F to 46°F); protect from light
Stability:Stable under recommended storage conditions
Mechanism of Action:Glycoprotein IIb/IIIa receptor antagonist
Pharmacological Class:Antiplatelet agent
Half-life:Approximately 2.5 hours
Administration Route:Intravenous injection

Eptifibatide Acetate is a cyclic heptapeptide that acts as a glycoprotein IIb/IIIa receptor antagonist. It is used as an antiplatelet agent to prevent blood clots in patients with acute coronary syndrome (ACS) or those undergoing percutaneous coronary intervention (PCI). By inhibiting the binding of fibrinogen to the glycoprotein IIb/IIIa receptor on platelets, eptifibatide prevents platelet aggregation and reduces the risk of thrombotic events. It is administered intravenously and has a relatively short half-life, making it suitable for acute clinical settings. Eptifibatide is a key therapeutic option in cardiology for managing high-risk cardiovascular conditions.

Certificate of Analysis (COA)
Product Name: Eptifibatide Acetate
CAS Number: 188627-80-7
Specification: USP/EP/In-house Standard
1. Physical and Chemical Properties
Parameter | Specification | Result | Method |
---|
Appearance | White to off-white powder | [Result] | Visual Inspection |
Solubility | Soluble in water | [Result] | USP/EP Method |
pH (1% solution) | 3.0 - 5.0 | [Result] | pH Meter |
Water Content | ≤ 5.0% | [Result] | Karl Fischer Titration |
2. Purity and Potency
Parameter | Specification | Result | Method |
---|
Assay (HPLC) | 98.0% - 102.0% | [Result] | HPLC |
Related Substances | ≤ 1.0% (Total Impurities) | [Result] | HPLC |
Single Unknown Impurity | ≤ 0.5% | [Result] | HPLC |
3. Microbiological Testing
Parameter | Specification | Result | Method |
---|
Total Aerobic Count | ≤ 100 CFU/g | [Result] | USP <61> |
Yeast and Mold | ≤ 10 CFU/g | [Result] | USP <61> |
Endotoxin | < 10 EU/mg | [Result] | USP <85> |
4. Residual Solvents
Parameter | Specification | Result | Method |
---|
Acetic Acid | ≤ 5000 ppm | [Result] | GC |
Other Solvents | Complies with ICH Q3C | [Result] | GC |
5. Additional Information
Storage Conditions: Store at 2-8°C, protected from light and moisture.
Packaging: Sealed in double polyethylene bags, placed in a fiber drum.
Shelf Life: 24 months from the date of manufacture.
Conclusion
The above batch of Eptifibatide Acetate complies with the specifications as per [USP/EP/In-house Standard].
