Description

Gemcitabine Hydrochloride is a potent nucleoside analog antimetabolite, a critical active pharmaceutical ingredient (API) in oncology. Its primary value lies in its mechanism of action, which inhibits DNA synthesis and induces apoptosis in rapidly dividing cells. This compound is essential for pharmaceutical manufacturers and research institutions developing treatments for various cancers, including pancreatic, non-small cell lung, breast, and ovarian cancers.

Application

• Oncological Pharmaceutical Manufacturing: As the key active ingredient in injectable chemotherapy formulations for commercial drug production.
• Clinical Research & Development: For preclinical and clinical studies investigating new cancer therapies or combination regimens.
• Generic Drug Formulation: Used by generic pharmaceutical companies to produce bioequivalent versions of branded gemcitabine products.
• Reference Standard: Serves as a high-purity analytical standard for quality control laboratories in pharmacopeial testing.
• Biochemical Research: Utilized in life science research to study cell cycle inhibition, nucleotide metabolism, and mechanisms of drug resistance.
• Veterinary Oncology: Applied in the development of chemotherapeutic treatments for certain cancers in animals.

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; (2R,3R,4S,5R)-2-(2,2-Difluoro-4-amino-7H-pyrrolo[2,3-d]pyrimidin-7-yl)-5-(hydroxymethyl)oxolane-3,4-diol hydrochloride; Gemzar® (brand name salt form); GEM HCl
EINECS	Contact for details

Quality Control

Our Gemcitabine Hydrochloride is manufactured under strict quality management systems. It is typically tested to meet high-purity standards suitable for pharmaceutical applications, with specifications aligning with major pharmacopeial guidelines. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results for identity, purity, assay, and impurity profiles to ensure regulatory compliance and batch-to-batch consistency.

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. This product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
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%
Related Substances (HPLC)	Individual impurity: ≤ 0.5%; Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Meets Ph. Eur./USP requirements

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