Active Pharmaceutical Ingredient

Gemcitabine Hydrochloride

Also known as: Gemzar

CAS: 122111-03-9 Antineoplastic / Antimetabolite IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Gemcitabine Hydrochloride API — Mediocon Inc
Gemcitabine Hydrochloride — Pharmaceutical Grade API

Product Overview

CAS No: 122111-03-9  |  MF: C9H12ClF2N3O4  |  MW: 299.66

Gemcitabine Hydrochloride is a pharmaceutical-grade active ingredient classified as Antineoplastic / Antimetabolite. Mediocon Inc supplies high-purity Gemcitabine Hydrochloride API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Gemcitabine Hydrochloride works by antimetabolite mechanism to provide therapeutic efficacy. It is used as a critical raw material in finished dosage form manufacturing for global pharmaceutical markets.

Key Features

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

Applications

  • Non-small cell lung cancer
  • Pancreatic cancer
  • Ovarian cancer
  • Bladder cancer and solid tumors

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 NameGemcitabine Hydrochloride
CAS Number122111-03-9
Molecular FormulaC9H12ClF2N3O4
Molecular Weight299.66
CategoryAntineoplastic / Antimetabolite
AppearanceWhite to off-white crystalline powder
GradeIP / BP / EP / USP
Batch NoGEM2503021
Mfg DateMAR 2025
Exp DateFEB 2030
Quantity25.00 Kg
Gross Weight26.00 Kg

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
Packing25 kg HDPE drums / as per requirement
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