Active Pharmaceutical Ingredient

Palonosetron Hydrochloride — CAS 135729-62-3

Also known as: Aloxi (brand); Palonosetron HCl

GMP Certified IP / BP / USP 5-HT3 Receptor Antagonist / Antiemetic Aurangabad, India
Palonosetron Hydrochloride API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Palonosetron Hydrochloride IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 135729-62-3

Product Overview

Palonosetron Hydrochloride is a second-generation 5-HT3 receptor antagonist with a high binding affinity and prolonged plasma half-life compared to first-generation agents. It is used for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). Mediocon Inc manufactures this API at its GMP-certified facility in Aurangabad, Maharashtra, India.

Therapeutic Applications
  • Prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV)
  • Prevention of post-operative nausea and vomiting (PONV)
  • Management of nausea in patients receiving moderately to highly emetogenic chemotherapy
  • Second-generation 5-HT3 antagonist in oncology supportive care

Technical Specifications

ParameterSpecification
CAS Number135729-62-3
Molecular FormulaC19H21N3O2·HCl
Molecular Weight383.85 g/mol
GradeIP / BP / USP
Category5-HT3 Receptor Antagonist / Antiemetic
AppearanceWhite to off-white crystalline powder
SolubilityFreely soluble in water, sparingly soluble in ethanol, practically insoluble in ether
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 NoPAL/24032026
Mfg DateMAR 2026
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 / 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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