Active Pharmaceutical Ingredient

Spiromustine — CAS 56605-16-4

Also known as: Spiromustinum

GMP Certified IP / BP / EP / USP Alkylating Antineoplastic Agent Aurangabad, India
Spiromustine API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Spiromustine IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 56605-16-4

Product Overview

Spiromustine is a bifunctional alkylating agent belonging to the nitrogen mustard class. It is primarily used in the treatment of brain tumors, particularly gliomas. Its mechanism involves cross-linking DNA strands, thereby inhibiting DNA replication and cell division. Mediocon Inc manufactures GMP-compliant Spiromustine API at its Aurangabad facility.

Therapeutic Applications
  • Brain tumor (glioma) treatment
  • Alkylating chemotherapy
  • Neoplastic disease management
  • Central nervous system cancers

Technical Specifications

ParameterSpecification
CAS Number56605-16-4
Molecular FormulaC₁₁H₁₉Cl₂N₃O
Molecular Weight284.19 g/mol
GradeIP / BP / EP / USP
CategoryAlkylating Antineoplastic Agent
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 NoSM/25030262
Mfg DateMAR 2025
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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