Active Pharmaceutical Ingredient

Gemcitabine

Also known as: Gemzar

CAS: 95058-81-4 Nucleoside Analogue / Antineoplastic IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Gemcitabine API — Mediocon Inc
Gemcitabine — Pharmaceutical Grade API

Product Overview

CAS No: 95058-81-4  |  MF: C9H11F2N3O4  |  MW: 263.19 g/mol

Gemcitabine is a nucleoside analogue antineoplastic agent used as first-line treatment for pancreatic cancer and non-small cell lung cancer. Mediocon Inc supplies pharmaceutical-grade Gemcitabine API with full regulatory documentation.

Key Features

  • Nucleoside analogue antimetabolite
  • First-line pancreatic cancer treatment
  • IP/BP/EP/USP compliant
  • Full CoA, MSDS, COO documentation

Applications

  • Pancreatic cancer
  • Non-small cell lung cancer
  • Bladder cancer
  • Combination chemotherapy regimens

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
Also Known AsGemzar
CAS Number95058-81-4
Molecular FormulaC9H11F2N3O4
Molecular Weight263.19 g/mol
CategoryNucleoside Analogue / Antineoplastic
AppearanceWhite to off-white crystalline powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay≥98.0% (as per pharmacopoeia)
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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