Active Pharmaceutical Ingredient

Topotecan Hydrochloride

Also known as: Hycamtin HCl; Topotecan HCl monohydrochloride

CAS: 119413-54-6Antineoplastic AgentIP / BP / EP / USPGMP CertifiedAurangabad, Maharashtra, India
Topotecan Hydrochloride API — Mediocon Inc
Topotecan Hydrochloride — Pharmaceutical Grade Antineoplastic API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 119413-54-6  |  MF: C₂₃H₂₃N₃O₅·HCl  |  MW: 457.90 g/mol

Topotecan Hydrochloride 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 Hydrochloride is the hydrochloride salt of topotecan, a topoisomerase I inhibitor used in oncology. It offers improved stability and water solubility for parenteral and oral formulation development.

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)
  • Small cell lung cancer
  • Cervical cancer therapy
  • Injectable oncology formulations

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 Hydrochloride
Also Known AsHycamtin HCl; Topotecan HCl monohydrochloride
CAS Number119413-54-6
Molecular FormulaC₂₃H₂₃N₃O₅·HCl
Molecular Weight457.90 g/mol
CategoryAntineoplastic Agent
AppearanceYellow to pale-yellow crystalline powder
SolubilityFreely soluble in water; slightly soluble in methanol
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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