Description

Gemcitabine is a potent nucleoside analog antimetabolite widely recognized for its critical role in oncology. This active pharmaceutical ingredient (API) is essential for the formulation of chemotherapeutic agents targeting specific cancer cell replication processes. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the development and production of oncology treatments, particularly for pancreatic, non-small cell lung, and breast cancers.

Application

• Oncology Drug Manufacturing: Primary API for injectable chemotherapy formulations such as Gemcitabine Hydrochloride.
• Pharmaceutical Research: Key reference standard and investigational compound in preclinical and clinical cancer research.
• Generic Drug Production: Serves as the core ingredient for generic versions of branded chemotherapy drugs.
• Combination Therapy Development: Used in research and formulation of combination chemotherapy regimens to enhance efficacy.
• Biochemical Studies: Employed in studies of DNA synthesis inhibition and cellular apoptosis mechanisms.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for pharmaceutical production.

Basic Information

Product Name	Gemcitabine
CAS No.	103882-84-4
Molecular Formula	C9H11F2N3O4
Molecular Weight	263.20 g/mol
Synonyms	2'-Deoxy-2',2'-difluorocytidine; dFdC; LY-188011; Gemzar (brand name API); (2R,3R,4S,5R)-2-(2,2-Difluoro-4-hydroxy-5-oxo-4,5-dihydro-1,3,2λ⁵-dioxaphospholan-2-yl)-3,4-dihydroxyoxolan-2-yl]methoxy-hydroxyphosphoryl] hydrogen phosphate; 4-Amino-1-(2-deoxy-2,2-difluoro-β-D-erythro-pentofuranosyl)pyrimidin-2(1H)-one; Difluorodeoxycytidine
EINECS	Contact for details

Quality Control

Our Gemcitabine is manufactured under strict quality management systems. Each batch is tested to meet high-purity standards suitable for pharmaceutical applications, with specifications aligning with major pharmacopoeial guidelines. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with every shipment to ensure traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as specified. Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.5%
Single Unknown Impurity	≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Meets Ph. Eur./USP criteria

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.