Active Pharmaceutical Ingredient

Piritrexim — CAS 3562-39-8

Also known as: BW301U; 2,4-diamino-6-(3,4-dichlorophenoxy)quinazoline

GMP Certified IP / BP / USP Dihydrofolate Reductase Inhibitor / Antiprotozoal Aurangabad, India
Piritrexim API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Piritrexim IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 3562-39-8

Product Overview

Piritrexim is a lipophilic antifolate that inhibits dihydrofolate reductase (DHFR) and was investigated for the treatment of Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis in immunocompromised patients. Mediocon Inc manufactures this API at its GMP-certified facility in Aurangabad, Maharashtra, India.

Therapeutic Applications
  • Treatment and prophylaxis of Pneumocystis jirovecii pneumonia (PCP)
  • Management of toxoplasmosis in immunocompromised patients
  • Investigational antifolate in oncology (bladder, prostate cancers)
  • Alternative to trimethoprim in sulfonamide-intolerant patients

Technical Specifications

ParameterSpecification
CAS Number3562-39-8
Molecular FormulaC7H4N4O2
Molecular Weight176.13 g/mol
GradeIP / BP / USP
CategoryDihydrofolate Reductase Inhibitor / Antiprotozoal
AppearanceYellow to orange crystalline powder
SolubilityFreely soluble in water, soluble in methanol, slightly soluble in ethanol
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 NoPIR/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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