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Ajmaline | CAS No: 4360-12-7 | GMP-certified suppliers
A medication that acts as a class Ia antiarrhythmic agent for managing atrial and ventricular arrhythmias and assisting in diagnostic evaluation of cardiac conduction abnormalities.
Therapeutic categories
Primary indications
- For use as an antiarrhythmic agent
Product Snapshot
- Ajmaline is formulated as an injectable solution concentrate intended for intravenous administration
- It is primarily used as an antiarrhythmic agent in cardiac arrhythmia management
- The product holds both approved and experimental regulatory statuses, depending on jurisdiction
Clinical Overview
Clinically, ajmaline is indicated as a class Ia antiarrhythmic agent. Its primary pharmacological action involves the modulation of cardiac electrophysiology via potent blockade of voltage-gated sodium channels, with a high affinity for the Nav 1.5 channel subtype expressed in myocardial tissue. This mechanism leads to a prolongation of the cardiac action potential by lengthening phase 0 depolarization and increasing the effective refractory period. These effects facilitate the correction of abnormal heart rhythms, particularly in atrial and ventricular arrhythmias.
Ajmaline possesses a notably short elimination half-life, rendering it suitable for acute intravenous administration in clinical settings. It has found application in managing atrial fibrillation in patients with Wolff–Parkinson–White syndrome, as well as in well-tolerated treatment of monomorphic ventricular tachycardias. Additionally, it serves a diagnostic role as a conduction system challenge agent, where it can unmask infranodal conduction defects indicated by abnormal prolongation of the HV interval. This diagnostic utility assists in identifying candidates for permanent pacemaker implantation in cases of syncope or bundle branch block.
From an absorption, distribution, metabolism, and excretion (ADME) perspective, detailed human pharmacokinetic data remain limited; however, the rapid clearance and intravenous route emphasize the need for controlled dosing and monitoring. Safety considerations include the potential for proarrhythmic effects and conduction disturbances, necessitating careful electrophysiological assessment during use. Ajmaline is also categorized among potential QTc-prolonging agents, underscoring the need for vigilance regarding ventricular repolarization abnormalities.
Several countries have approved ajmaline for clinical use, though its status may vary globally and occasionally be restricted to experimental or diagnostic applications.
For pharmaceutical sourcing, quality assurance of ajmaline active pharmaceutical ingredient (API) requires confirmation of structural integrity, purity, and compliance with pharmacopeial standards specific to alkaloid-based antiarrhythmics. Stability profiles and impurity characterization are critical due to the complex natural origin and potential for batch-to-batch variability. Reliable suppliers should provide validated analytical documentation aligning with international regulatory expectations to ensure consistent clinical performance.
Identification & chemistry
| Generic name | Ajmaline |
|---|---|
| Molecule type | Small molecule |
| CAS | 4360-12-7 |
| UNII | 1PON08459R |
| DrugBank ID | DB01426 |
Pharmacology
| Summary | Ajmaline is a class IA antiarrhythmic agent that targets the Nav1.5 sodium channel (sodium channel protein type 5 subunit alpha). It modulates cardiac sodium currents, prolonging the action potential duration to help restore normal heart rhythms. Its primary pharmacodynamic effect is the inhibition of abnormal electrical conduction in cardiac tissue. |
|---|---|
| Mechanism of action | The class I antiarrhythmic agents interfere with the sodium channel. A class IA agent lengthens the action potential (right shift) which brings about improvement in abnormal heart rhythms. This drug in particular has a high affinity for the Nav 1.5 sodium channel. |
| Pharmacodynamics | Ajmaline is a class 1A antiarrhythmic agent. By interfering with the sodium channels, this drug allows for improvement in abnormal rhythms of the heart |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium channel protein type 5 subunit alpha | Humans | inhibitor |
Formulation & handling
- Ajmaline is a small molecule suitable for intravenous administration as a concentrated solution.
- Moderate water solubility supports formulation as an injectable without complex solubilization techniques.
- Handling should account for stability in aqueous solution to maintain efficacy during storage and administration.
Regulatory status
Ajmaline is a type of Anti-arrhythmics
Anti-arrhythmics belong to the pharmaceutical API category designed to treat irregular heart rhythms, also known as arrhythmias. These medications work by targeting the electrical signals in the heart, helping to regulate the heart's rhythm and restore it to a normal, steady beat.
Anti-arrhythmics are crucial in managing various types of arrhythmias, such as atrial fibrillation, ventricular tachycardia, and supraventricular tachycardia. These conditions can pose serious risks, including an increased likelihood of stroke or heart failure. Hence, anti-arrhythmics play a vital role in improving patient outcomes and reducing these associated risks.
Pharmaceutical companies develop anti-arrhythmic APIs, which are the active ingredients used to formulate the final medications. These APIs undergo rigorous testing and quality control measures to ensure their safety, efficacy, and consistent performance. They are manufactured in accordance with Good Manufacturing Practices (GMP) guidelines to meet the highest quality standards.
Healthcare professionals prescribe anti-arrhythmics based on the specific arrhythmia type, severity, and individual patient factors. These APIs can be formulated into different dosage forms, including tablets, capsules, or intravenous solutions, depending on the desired route of administration and patient requirements.
It is important to note that anti-arrhythmics are prescription-only medications and should only be used under medical supervision. Patients using these medications must follow their healthcare provider's instructions and regularly monitor their heart rhythm to ensure optimal treatment effectiveness and minimize potential side effects.
In conclusion, anti-arrhythmics are a crucial category of pharmaceutical APIs used to treat various types of irregular heart rhythms. They are formulated into medications that help regulate the heart's electrical signals, reduce associated risks, and improve patient outcomes.
Ajmaline API manufacturers & distributors
Compare qualified Ajmaline API suppliers worldwide. We currently have 2 companies offering Ajmaline API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Eigenmann & Veronelli | Producer | Italy | Italy | CoA, GMP | 6 products |
| Indena | Producer | Italy | France | CoA, GMP | 15 products |
When sending a request, specify which Ajmaline API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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