Disopyramide is a synthetic Class IA antiarrhythmic pharmaceutical active ingredient used in the management of certain cardiac arrhythmias. It acts primarily by blocking voltage-gated sodium channels and slowing cardiac conduction.
Disopyramide has the molecular formula C21H29N3O, a molecular weight of 339.47 g/mol, and CAS No. 3737-09-5.
Disopyramide is a Class IA antiarrhythmic agent. It produces membrane-stabilizing effects by reducing the rapid inward sodium current in cardiac tissue. It also has anticholinergic properties that can contribute to some of its pharmacological effects.
Disopyramide decreases the excitability and conduction velocity of cardiac tissue and prolongs the effective refractory period. Its electrophysiological effects can help suppress certain abnormal cardiac rhythms.
Disopyramide primarily blocks fast voltage-gated sodium channels in cardiac myocytes. This reduces the rate of phase 0 depolarization and slows conduction.
It also prolongs cardiac action-potential duration and the effective refractory period, consistent with its classification as a Class IA antiarrhythmic.
Disopyramide is used in appropriate clinical settings for certain cardiac rhythm disorders, including:
The approved indication and availability of disopyramide vary by country and regulatory authority.
Disopyramide is relevant to pharmaceutical manufacturers and formulation-development organizations working on antiarrhythmic and cardiovascular pharmaceutical products.
It is commonly associated with oral dosage forms and may also be available in specific parenteral formulations depending on the market.
Disopyramide API quality evaluation may include:
Testing should be performed using validated analytical methods appropriate for the API and intended formulation.
Disopyramide intended for pharmaceutical manufacturing should comply with applicable GMP, quality-control and regulatory requirements.
The final API specification should be established according to the intended market, applicable pharmacopoeial requirements and the manufacturer's approved product specification.
A batch-specific Certificate of Analysis (CoA) should provide relevant analytical results and acceptance criteria.
Disopyramide API should be stored in tightly closed, appropriately labelled containers under the manufacturer's recommended storage conditions. Protection from excessive heat, moisture and unsuitable environmental exposure should be maintained.
Disopyramide is relevant to pharmaceutical companies involved in the development and manufacture of antiarrhythmic and cardiovascular formulations.
For commercial applications, customers should verify the API identity, chemical form, grade, assay, purity, impurity profile, regulatory documentation and batch-specific CoA before use.
Consistent Disopyramide API quality is important for reliable formulation development and pharmaceutical manufacturing. Control of identity, assay, purity and related substances supports reproducible product quality.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |