Description

Gemcitabinehcl CAS NO 12111-03-9 is the hydrochloride salt of Gemcitabine, a potent nucleoside analog antimetabolite. This compound is a critical active pharmaceutical ingredient (API) used in the synthesis of chemotherapeutic agents. It is primarily required by pharmaceutical manufacturers and research institutions developing oncology treatments, particularly for pancreatic, lung, breast, and bladder cancers.

Application

• Oncological Pharmaceutical Manufacturing: Primary use as the active pharmaceutical ingredient (API) in injectable chemotherapy formulations.
• Anticancer Drug Synthesis: Serves as a key intermediate in the production of finished dosage forms like Gemcitabine hydrochloride for injection.
• Biomedical Research: Utilized in preclinical and clinical studies to investigate mechanisms of action, efficacy, and new combination therapies for various carcinomas.
• Pharmaceutical Reference Standard: Employed as a high-purity standard for quality control and analytical method development in regulatory testing.
• Drug Delivery System Development: Used in research for novel delivery mechanisms such as liposomal, nanoparticle, or targeted therapy systems to improve efficacy and reduce side effects.

Basic Information

Product Name	Gemcitabinehcl
CAS No.	12111-03-9
Molecular Formula	C9H12F2N3O4 • HCl
Molecular Weight	299.66 g/mol (Free base: 263.20)
Synonyms	Gemcitabine Hydrochloride; 2'-Deoxy-2',2'-difluorocytidine monohydrochloride; LY-188011 hydrochloride; dFdC hydrochloride; 4-Amino-1-(2-deoxy-2,2-difluoro-β-D-erythro-pentofuranosyl)-2(1H)-pyrimidinone monohydrochloride; Gemzar® (brand name API); (2R,3R,4S,5R)-2-(4-Amino-2-oxopyrimidin-1-yl)-4-fluoro-5-(hydroxymethyl)oxolan-3-yl hydrogen phosphate hydrochloride
EINECS	Contact for details

Quality Control

Our Gemcitabinehcl is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. Certificates of Analysis (COA) documenting compliance with relevant pharmacopeial standards (such as USP/EP) are provided with every shipment.

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 on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5%; Total impurities: ≤ 2.0%
Microbial Enumeration	Meets USP/EP criteria

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