Disopyramide Phosphate is the phosphate salt of Disopyramide, a Class IA antiarrhythmic active pharmaceutical ingredient used for the management of certain cardiac arrhythmias. It acts primarily by blocking cardiac sodium channels and also affects potassium-channel-mediated cardiac repolarization.
Disopyramide Phosphate has CAS Number 22059-60-5, molecular formula C₂₁H₃₂N₃O₅P, and molecular weight 437.5 g/mol. It is a pharmaceutical salt consisting of disopyramide and phosphoric acid in a 1:1 relationship.
Disopyramide Phosphate belongs to the Class IA antiarrhythmic group. It produces membrane-stabilizing effects through sodium-channel blockade and prolongs cardiac action-potential duration and effective refractory periods.
Disopyramide Phosphate affects cardiac electrophysiology by reducing the rate of depolarization and slowing impulse conduction. Its effects on cardiac ion channels contribute to its antiarrhythmic activity.
Disopyramide Phosphate primarily blocks fast sodium channels in cardiac tissue. This decreases the rapid inward sodium current during phase 0 of the cardiac action potential and slows conduction.
It also prolongs the action-potential duration and effective refractory period, supporting its classification as a Class IA antiarrhythmic agent.
Disopyramide Phosphate is associated with pharmaceutical formulations for the management of certain cardiac rhythm disorders, including applicable ventricular and supraventricular arrhythmias.
The exact approved indication, dosage form and availability should be verified according to the regulatory requirements of the intended market.
Disopyramide Phosphate is relevant to pharmaceutical manufacturers and formulation-development organizations working on cardiovascular and antiarrhythmic medicines.
It is particularly suitable for development and manufacturing of pharmaceutical products containing the phosphate salt form of disopyramide.
Quality evaluation of Disopyramide Phosphate may include:
Exact acceptance criteria should be taken from the approved product specification and current batch CoA.
Disopyramide Phosphate intended for pharmaceutical manufacturing should comply with applicable GMP, quality-control and regulatory requirements.
The API should be manufactured, tested, packaged and stored according to the applicable specification for the intended pharmaceutical market.
A batch-specific Certificate of Analysis (CoA) should provide the applicable analytical results and acceptance criteria.
Disopyramide Phosphate 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 Phosphate is relevant to pharmaceutical organizations involved in the development and manufacture of antiarrhythmic and cardiovascular formulations.
For commercial pharmaceutical applications, customers should verify the CAS number, salt form, grade, assay, purity, impurity profile, regulatory documentation and batch-specific CoA before use.
Consistent quality of Disopyramide Phosphate is important for reliable formulation development and manufacturing. Proper control of identity, assay, purity, related substances and physical characteristics supports consistent pharmaceutical 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% |