Description

Gemicitabine Hydrochloride is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) with the CAS number 197452-45-2. This compound is a critical building block in the synthesis of advanced nucleoside analogs, offering significant value in modern therapeutic development. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development of antiviral and anticancer agents, where consistent quality and reliable supply are paramount.

Application

• Pharmaceutical API Synthesis: Serves as a key intermediate in the production of nucleoside-based antiviral and anticancer drugs.
• Oncology Research: Used in preclinical and clinical research for developing novel chemotherapeutic agents targeting DNA synthesis.
• Antiviral Drug Development: Employed in the research and synthesis of medications designed to inhibit viral replication.
• Biochemical Research: Utilized as a standard or reagent in studies involving nucleotide metabolism and enzyme inhibition.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for cGMP-compliant drug production.
• Reference Standard: Serves as a high-purity analytical standard for quality control and method validation in pharmaceutical laboratories.

Basic Information

Product Name	Gemicitabine Hydrochloride
CAS No.	197452-45-2
Molecular Formula	C9H12ClN3O4 • HCl
Molecular Weight	299.57 g/mol (for hydrochloride salt)
Synonyms	Gemcitabine HCl; 2'-Deoxy-2',2'-difluorocytidine monohydrochloride; LY-188011 hydrochloride; dFdC hydrochloride; 4-Amino-1-((2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)pyrimidin-2(1H)-one hydrochloride
EINECS	Contact for details

Quality Control

Our Gemicitabine Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identification by spectroscopic methods, to ensure it meets stringent specifications for pharmaceutical use. Certificates of Analysis (COA) are provided with each shipment, detailing compliance with relevant in-house or client-specific standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 2.0%

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