Items | Specifications | Results |
Appearance | White crystalline powder. | White crystalline powder |
Solubility | Freely soluble in water，almost insoluble in ethanol and chloroform or ether. | Conforms |
Melting point | 204 ~ 207℃ | 204.0 ~ 204.5℃ |
Identification | The Infrared absorption spectrum is concordant with the reference spectrum. | Conforms |
Clarity of solution | Should be conform | Conforms |
pH | 7.5 ~ 8.0 | 7.9 |
Sulfate | ≤0.01% | Conforms |
Calciumion | Should be conform | Conforms |
Loss on drying | ≤0.5% | 0.04% |
Water by KF | ≤0.5% | 0.03% |
Residual on ignition | ≤0.1% | 0.08% |
Heavy Metals | ≤10ppm | Conforms |
Arsenic salt | ≤2ppm | Conforms |
Appearance of solution | Should be conform | Conforms |
Microbial limit | Total aerobic bacteria≤103cfu/g. | ＜10cfu/g |
Mildew and yeast number≤102cfu/g. | ＜10cfu/g |
Escherichia coli can not be detected. | Not detected |
Absorbance | A. 287 nm, ≤0.10 B. 450 nm, ≤0.03 | A. 287 nm, 0.032 450 nm, 0.002 |
B. 287 nm, ≤0.15 450 nm, ≤0.03 | B. 287 nm, 0.109 450 nm, 0.009 |
Assay | ≥98.5% (calculated on the anhydrous basis) | 99.6% (Titration) 99.8% (HPLC) |
Conclusion | The product conforms to the standard of EP /USP. |
6-Aminocaproic acid (also known as ε-aminocaproic acid or EACA) is a lysine analog and a fibrinolytic inhibitor—a compound that helps prevent the breakdown of blood clots. Its chemical formula is C?H??NO?, and it is a white, crystalline powder that is soluble in water.
Mechanism of Action
6-Aminocaproic acid works by inhibiting plasminogen activation, thereby reducing the formation of plasmin, the enzyme responsible for breaking down fibrin clots. By blocking this process, EACA helps stabilize blood clots and reduce bleeding.
Primary Medical Uses:
Treatment and Prevention of Excessive Bleeding:
Used in conditions involving hyperfibrinolysis (excessive clot breakdown), such as:
After cardiac surgery or prostate surgery
In liver disease
During trauma or massive transfusion
Dental Procedures in Patients with Bleeding Disorders:
Helps control bleeding in people with hemophilia or other coagulopathies during minor oral surgeries.
Hereditary Angioedema (off-label use):
Sometimes used to reduce the frequency and severity of swelling attacks, though not a first-line therapy.
Menorrhagia (heavy menstrual bleeding):
Occasionally prescribed off-label for acute management.
Administration:
Available orally (tablets) or intravenously (IV infusion), typically in hospital settings for acute bleeding.
Safety Considerations:
Contraindicated in patients with disseminated intravascular coagulation (DIC) or active thromboembolic disease.
Potential side effects: nausea, hypotension, muscle weakness, seizures (especially with high IV doses), and increased risk of blood clots.
Should be used cautiously in patients with kidney impairment, as it is excreted renally.
In summary, 6-aminocaproic acid is a valuable antifibrinolytic agent primarily used to control or prevent bleeding in specific clinical situations where excessive clot dissolution is a concern.
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