Active Pharmaceutical Ingredient

Ondansetron Hydrochloride — CAS 99614-02-5

Also known as: Ondansetron HCl; GR-38032F; Zofran HCl

GMP Certified IP / BP / EP / USP 5-HT3 Antagonist / Antiemetic Aurangabad, India
Ondansetron Hydrochloride API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Ondansetron Hydrochloride IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 99614-02-5

Product Overview

Ondansetron Hydrochloride is a high-purity Active Pharmaceutical Ingredient (API) classified as a 5-HT3 Antagonist / Antiemetic. Manufactured by Mediocon Inc in Aurangabad, Maharashtra, India at a GMP-certified facility, it is supplied in bulk for pharmaceutical formulations worldwide. CAS No: 99614-02-5.

Therapeutic Applications
  • Prevention of nausea and vomiting from chemotherapy
  • Prevention of radiation-induced nausea
  • Post-operative nausea and vomiting (PONV)
  • Hyperemesis gravidarum (off-label)
  • Gastroparesis management

Technical Specifications

ParameterSpecification
CAS Number99614-02-5
Molecular FormulaC18H19N3O · HCl · 2H2O
Molecular Weight365.85 g/mol (dihydrate)
GradeIP / BP / EP / USP
Category5-HT3 Antagonist / Antiemetic
AppearanceWhite to off-white powder
SolubilityFreely soluble in water; soluble in methanol; slightly soluble in chloroform
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
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 / 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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