Active Pharmaceutical Ingredient

Sotalol — CAS 3930-20-9

Also known as: Betapace; Sorine; Rytmobeta

GMP Certified IP / BP / EP / USP Antiarrhythmic / Beta-Blocker Aurangabad, India
Sotalol API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Sotalol IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 3930-20-9

Product Overview

Sotalol is a non-selective beta-adrenergic receptor blocking agent with additional Class III antiarrhythmic properties. It is used to treat life-threatening ventricular arrhythmias and atrial fibrillation. Mediocon Inc manufactures GMP-compliant Sotalol API at its Aurangabad facility to international pharmacopoeial standards.

Therapeutic Applications
  • Life-threatening ventricular arrhythmias
  • Atrial fibrillation and flutter
  • Cardiac rhythm management
  • Beta-adrenergic blockade

Technical Specifications

ParameterSpecification
CAS Number3930-20-9
Molecular FormulaC₁₂H₂₀N₂O₃S
Molecular Weight272.36 g/mol
GradeIP / BP / EP / USP
CategoryAntiarrhythmic / Beta-Blocker
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoST/25030256
Mfg DateMAR 2025
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / EP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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