Description

Gemcitabine is a potent nucleoside analog antimetabolite that plays a critical role in modern oncology. Its primary value lies in its ability to inhibit DNA synthesis, making it a cornerstone chemotherapeutic agent. This high-purity active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers and research institutions developing treatments for various cancers.

Application

• Oncological Formulations: Primary active ingredient in injectable chemotherapy drugs for the treatment of pancreatic, non-small cell lung, breast, ovarian, and bladder cancers.
• Pharmaceutical R&D: Used in preclinical and clinical research for developing new anticancer therapies and combination regimens.
• Generic Drug Manufacturing: Serves as the key API for producers of generic gemcitabine hydrochloride formulations.
• Drug Delivery System Development: Investigated for incorporation into liposomal, nanoparticle, or other advanced delivery platforms to enhance efficacy and reduce side effects.
• Reference Standard: Utilized as a high-purity analytical standard in quality control laboratories for HPLC, LC-MS, and other pharmacopeial testing methods.
• Biochemical Research: Employed in studies of cell cycle inhibition, apoptosis mechanisms, and nucleotide metabolism.

Basic Information

Product Name	Gemcitabine
CAS No.	95058-81-4
Molecular Formula	C9H11F2N3O4
Molecular Weight	263.20 g/mol
Synonyms	Gemcitabine Base; 2'-Deoxy-2',2'-difluorocytidine; dFdC; LY-188011; Gemzar (Brand Name); 4-Amino-1-(2-deoxy-2,2-difluoro-β-D-erythro-pentofuranosyl)pyrimidin-2(1H)-one; 2'-Deoxy-2',2'-difluorocytidine
EINECS	Contact for details

Quality Control

Our Gemcitabine is manufactured under strict quality management systems. It is tested to meet or exceed relevant pharmacopeial standards (such as USP/EP) for identity, purity, and potency. Comprehensive testing includes assay, related substances, residual solvents, and microbiological examination. A Certificate of Analysis (COA) documenting all test results is provided with each batch to ensure full traceability and 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). This product 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
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water Content (KF)	NMT 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	NMT 20 ppm
Microbial Enumeration	Complies with USP <61>

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