Active Pharmaceutical Ingredient

Sotalol

Also known as: Sotalol HCl; Betapace; Sotacor

CAS: 3930-20-9 Class III Antiarrhythmic BP / EP / USP / INH / FCC / NF GMP Certified Aurangabad, Maharashtra, India
Sotalol API — Mediocon Inc
Sotalol — Pharmaceutical Grade API

Product Overview

CAS No: 3930-20-9  |  MF: C₁₂H₂₀N₂O₃S  |  MW: 272.37 g/mol

Sotalol is a non-selective beta-adrenergic blocking agent with additional Class III antiarrhythmic properties used as an active pharmaceutical ingredient. Mediocon Inc supplies high-purity Sotalol API conforming to BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

Sotalol prolongs cardiac action potential duration and the effective refractory period through potassium channel blockade, in addition to beta-adrenoceptor blocking activity. It is used for the management of life-threatening ventricular arrhythmias and atrial fibrillation.

Key Features

  • High-purity pharmaceutical grade API
  • BP / EP / USP / INH / FCC / NF compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Ventricular tachycardia and fibrillation
  • Atrial fibrillation and flutter
  • Supraventricular tachycardia
  • Postoperative arrhythmia management

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameSotalol
Also Known AsSotalol HCl; Betapace; Sotacor
CAS Number3930-20-9
Molecular FormulaC₁₂H₂₀N₂O₃S
Molecular Weight272.37 g/mol
CategoryClass III Antiarrhythmic — Beta-Blocker
AppearanceWhite to off-white crystalline powder
SolubilityFreely soluble in water; slightly soluble in ethanol
GradeBP / EP / USP / INH / FCC / NF

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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