Description

Gemcitabine Hydrochloride is a potent nucleoside analog antimetabolite, widely recognized as a critical active pharmaceutical ingredient (API) in oncology. Its primary value lies in its mechanism of action, which inhibits DNA synthesis and is essential for the formulation of chemotherapeutic treatments. This compound is a fundamental raw material for pharmaceutical manufacturers and research institutions developing therapies for various cancers, including pancreatic, non-small cell lung, breast, and ovarian cancers.

Application

• Pharmaceutical API Manufacturing: Primary use as the active ingredient in injectable chemotherapy formulations (e.g., Gemzar®).
• Oncology Drug Development: Serves as a key reference standard and building block in preclinical and clinical research for new anticancer agents.
• Generic Drug Production: Essential for manufacturers producing bioequivalent versions of branded gemcitabine hydrochloride drugs.
• Combination Therapy Research: Used in studies exploring synergistic effects with other chemotherapeutic agents or radiotherapy.
• Biochemical Research: Employed in laboratory studies to investigate cell cycle inhibition, apoptosis mechanisms, and nucleotide metabolism.
• Dosage Form Development: Utilized in R&D for developing novel delivery systems such as liposomal or nanoparticle-based formulations to improve efficacy and reduce side effects.

Basic Information

Product Name	Gemcitabine Hydrochloride
CAS No.	122111-03-9
Molecular Formula	C9H11F2N3O4 • HCl
Molecular Weight	299.66 g/mol (Free base: 263.20)
Synonyms	Gemcitabine HCl; 2'-Deoxy-2',2'-difluorocytidine monohydrochloride; dFdC HCl; LY-188011 HCl; Gemzar® (brand name hydrochloride salt); (2R,3R,4S,5R)-2-(4-Amino-2-oxopyrimidin-1-yl)-4-fluoro-5-(hydroxymethyl)oxolan-3-yl]oxyphosphonic acid hydrochloride; 1-(4-Amino-2-oxo-1(2H)-pyrimidinyl)-2-deoxy-2,2-difluororibose hydrochloride
EINECS	Contact for details

Quality Control

Our Gemcitabine Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. We provide Certificates of Analysis (COA) detailing specifications for identity, purity, assay, and related substances, with testing performed via validated methods such as HPLC, NMR, and IR spectroscopy. Compliance with relevant pharmacopeial guidelines (e.g., USP, EP) is a key focus of our quality assurance process.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), or as indicated on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term stability, consider storage under inert atmosphere conditions.

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)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%; Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Specific Rotation	+48° to +52° (c=1 in water)
pH (1% Solution)	2.0 - 3.0

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