Active Pharmaceutical Ingredient

Pirarubicin Hydrochloride — CAS 155596-90-0

Also known as: Pirarubicin HCl; THP-Adriamycin Hydrochloride

GMP Certified IP / BP / USP Antineoplastic Agent (Anthracycline) Aurangabad, India
Pirarubicin Hydrochloride API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Pirarubicin Hydrochloride IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 155596-90-0

Product Overview

Pirarubicin Hydrochloride is the hydrochloride salt form of pirarubicin, an anthracycline antineoplastic agent. As the hydrochloride salt, it offers improved water solubility and formulation stability. It is used in oncology for the treatment of various cancers including breast cancer and bladder tumors. Mediocon Inc manufactures Pirarubicin Hydrochloride API at its GMP-certified facility in Aurangabad, Maharashtra, India.

Therapeutic Applications
  • Treatment of breast cancer in adjuvant and metastatic settings
  • Intravesical instillation therapy for bladder cancer
  • Treatment of acute leukemia and lymphoma
  • Combination chemotherapy regimens for solid tumors

Technical Specifications

ParameterSpecification
CAS Number155596-90-0
Molecular FormulaC32H35NO12 · HCl
Molecular Weight664.08 g/mol
GradeIP / BP / USP
CategoryAntineoplastic Agent (Anthracycline)
AppearanceRed to reddish-purple crystalline powder
SolubilityFreely soluble in water, sparingly soluble in ethanol, practically insoluble in ether
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 NoPIRH/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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