Storage
Store at room temperature
Synonyms
Bepridil HCl; Angopril; 1978CERM; UNII-2TN7FF3W4M; Bepridil hydrochloride anhydrous
Molecular Formula
C24H35ClN2O
Smiles
CC(C)COCC(CN(CC1=CC=CC=C1)C2=CC=CC=C2)N3CCCC3.Cl
Appearance
White to light yellow solid powder
Boiling Point
492.3°C at 760 mmHg
General Description
Bepridil hydrochloride is a calcium channel blocker with a unique diphenylalkylamine structure, containing a pyrrolidine ring and a phenyl group. Its chemical structure is N‑(2‑ethylamino)‑3‑(3‑isobutoxy‑2‑pyrrolidinyl)‑2‑methylpropanamide hydrochloride.
Mechanism of Action
Bepridil acts as a calcium channel blocker with additional class I antiarrhythmic properties, inhibiting both calcium and sodium channels in cardiac and vascular tissues. It reduces heart rate and myocardial contractility, decreases peripheral vascular resistance, and prolongs the action potential duration. The drug also has a mild local anesthetic effect.
Application
Bepridil was indicated for the treatment of chronic stable angina and for the management of supraventricular and ventricular arrhythmias.
In 76 patients with persistent atrial fibrillation, response to bepridil (≤200 mg/day) before ablation was associated with a lower low-voltage zone (LVZ) ratio (7.5% vs 14.0%, P=0.009) and higher 1-year recurrence-free survival after ablation (87.1% vs 62.3%, P=0.03). Response to bepridil is a marker of normal atrial voltage and predicts better outcomes after catheter ablation.
Fig. 1 Recurrence‐free rates after catheter ablation. (Yakabe D, et al., 2021)
References
- Yakabe D, et al. Responsiveness to bepridil predicts atrial substrate in patients with persistent atrial fibrillation. J Arrhythm. 2021;37(1):79-87.
Does Bepridil Hydrochloride require protection from light during storage?
Yes, it is photosensitive. UV exposure can cause photodegradation and discoloration. Store in light-resistant containers, preferably amber glass.
What is the recommended storage temperature for Bepridil Hydrochloride?
Store at controlled room temperature (15-25°C). Avoid excessive heat above 30°C, which can accelerate oxidation of the pyrrolidine ring.
Is Bepridil Hydrochloride hygroscopic, and how is this managed?
It is slightly hygroscopic. Under high humidity (>70% RH), it may absorb moisture and clump. Storage in tightly sealed containers with desiccant is recommended.
How is the impurity bepridil N-oxide (an oxidative degradation product) monitored?
This degradation product is quantified using a stability-indicating HPLC method, ensuring it remains within ICH qualification thresholds.