Active Pharmaceutical Ingredient

Tolvaptan

Also known as: Samsca; Jynarque; OPC-41061

CAS: 150683-30-0Vasopressin V₂ Antagonist / APIIP / BP / EP / USPGMP CertifiedAurangabad, Maharashtra, India
Tolvaptan API — Mediocon Inc
Tolvaptan — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 150683-30-0  |  MF: C₂₆H₂₅ClN₂O₃  |  MW: 448.94 g/mol

Tolvaptan is a high-purity Active Pharmaceutical Ingredient supplied by Mediocon Inc conforming to IP / BP / EP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India.

Tolvaptan is a selective, oral vasopressin V₂-receptor antagonist (vaptant) that blocks the effects of vasopressin (antidiuretic hormone) in the kidney. It promotes aquaresis (free water excretion) without significant electrolyte loss and is approved for hyponatremia and autosomal dominant polycystic kidney disease (ADPKD).

Key Features

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

Applications

  • Hyponatremia treatment (SIADH)
  • Autosomal dominant polycystic kidney disease (ADPKD)
  • Euvolemic and hypervolemic hyponatremia
  • Heart failure-related fluid retention

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 NameTolvaptan
Also Known AsSamsca; Jynarque; OPC-41061
CAS Number150683-30-0
Molecular FormulaC₂₆H₂₅ClN₂O₃
Molecular Weight448.94 g/mol
CategoryVasopressin V₂-Receptor Antagonist / Active Pharmaceutical Ingredient
AppearanceWhite to off-white crystalline powder
SolubilityPractically insoluble in water; soluble in methanol and DMSO
GradeIP / BP / EP / USP

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
Batch No.TVP/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement
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