Active Pharmaceutical Ingredient

Sotalol API Manufacturer & Supplier in India

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

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Sotalol (CAS 3930-20-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Sotalol is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Sotalol API

What is the minimum order quantity for Sotalol API?
Mediocon Inc supplies Sotalol with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Sotalol does Mediocon supply?
We supply Sotalol conforming to BP / EP / USP / INH / FCC / NF pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Sotalol API?
Every shipment of Sotalol comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Sotalol bulk orders?
Standard lead time for Sotalol is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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