Active Pharmaceutical Ingredient

Topotecan

Also known as: Hycamtin; SK&F 104864

Antineoplastic AgentIP / BP / EP / USPGMP CertifiedAurangabad, Maharashtra, India
Topotecan API — Mediocon Inc
Topotecan — Pharmaceutical Grade Antineoplastic API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

Category: Antineoplastic Agent (Topoisomerase I Inhibitor)  |  Grade: IP / BP / EP / USP

Topotecan is a high-purity Antineoplastic Agent supplied by Mediocon Inc as an Active Pharmaceutical Ingredient (API) conforming to IP / BP / EP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India, it meets the stringent quality requirements of global pharmaceutical manufacturers.

Topotecan is a semisynthetic derivative of camptothecin and a topoisomerase I inhibitor used in oncology for the treatment of ovarian cancer, small cell lung cancer, and cervical cancer.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing facility

Applications

  • Ovarian cancer (second-line treatment)
  • Small cell lung cancer
  • Cervical cancer
  • Antineoplastic formulation development

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameTopotecan
Also Known AsHycamtin; SK&F 104864
CAS Number123948-87-8
Molecular FormulaC₂₃H₂₃N₃O₅
Molecular Weight421.44 g/mol
CategoryAntineoplastic Agent
AppearanceYellow to light-yellow powder
SolubilitySoluble in water at acidic pH; soluble in DMSO
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
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 No.TPT/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement
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