CAS number: 141625-93-6
Therapeutic segment: Cardiovascular/Antiarrhythmic
API class/drug class: Class III Antiarrhythmic Agent (Multichannel Blocker)
Chemical name: N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-1-benzofuran-5-yl]methanesulfonamide;hydrochloride
Molecular formula: C31H45ClN2O5S
Molecular weight: 593.2 g/mol
Form: White to off-white crystalline powder
Packaging type: Double LDPE bags packed in HDPE drums or equivalent pharma-grade, moisture-protective packaging
Storage conditions: Store in a cool, dry place; protect from light and moisture. Keep the container tightly closed
Specification: As per USP/PhEur/IP (as applicable) or in-house specifications
Application area: Used in pharmaceutical formulations for the management of atrial fibrillation and atrial flutter in appropriate patient populations
GMP: Y
DMF: Y
USFDA: Y
EDQM: Y

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Product Description:

Dronedarone Hydrochloride is a Class III antiarrhythmic API, supplied as a white to off-white crystalline powder used in pharmaceutical formulations for the management

of atrial fibrillation and atrial flutter. It exerts its antiarrhythmic effect through multi-channel blockade, inhibiting sodium, potassium, and calcium ion channels, alongside non-competitive anti-adrenergic activity, resulting in rate and rhythm control in patients with supraventricular arrhythmias. The API is packaged in double LDPE bags within HDPE drums or equivalent pharma-grade, moisture-protective containers to ensure stability under recommended storage conditions.

As a leading distribution partner, Molkem Chemicals ensures reliable supply of products aligned with industry quality standards and regulatory expectations. Each product is delivered as per agreed specifications, supported by standard documentation including COA, SDS, and TDS. If required, our technical team can provide additional stability data and regulatory assistance.

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