Active Pharmaceutical Ingredient

Oteracil Potassium — CAS 220210-56-0

Also known as: Potassium Oxonate; 5-Chloro-2,4-dihydroxypyridine potassium salt

GMP Certified IP / BP / EP / USP 5-Fluorouracil Modulator / Antineoplastic Adjunct Aurangabad, India
Oteracil Potassium API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Oteracil Potassium IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 220210-56-0

Product Overview

Oteracil Potassium is a high-purity Active Pharmaceutical Ingredient (API) classified as a 5-Fluorouracil Modulator / Antineoplastic Adjunct. Manufactured by Mediocon Inc in Aurangabad, Maharashtra, India at a GMP-certified facility, it is supplied in bulk for pharmaceutical formulations worldwide. CAS No: 220210-56-0.

Therapeutic Applications
  • Component of S-1 (tegafur/gimeracil/oteracil) anticancer regimen
  • Gastric cancer treatment in combination therapy
  • Reduction of gastrointestinal toxicity of fluorouracil
  • Colorectal cancer adjuvant therapy
  • Pancreatic and biliary tract cancer management

Technical Specifications

ParameterSpecification
CAS Number220210-56-0
Molecular FormulaC4H3ClKN3O2
Molecular Weight211.64 g/mol
GradeIP / BP / EP / USP
Category5-Fluorouracil Modulator / Antineoplastic Adjunct
AppearanceWhite to off-white crystalline powder
SolubilitySoluble in water; slightly soluble in methanol
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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