Description

Gemcitabine-13C,15N2 Hydrochloride is a stable isotope-labeled analog of the widely used chemotherapeutic agent, gemcitabine. This compound is specifically designed for use as an internal standard in quantitative bioanalytical methods, ensuring unparalleled accuracy and reliability in pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical R&D, clinical research laboratories, and contract research organizations (CROs) engaged in the development and analysis of nucleoside-based anticancer therapies.

Application

• Bioanalytical Internal Standard: Primary use as a reference standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of gemcitabine and its metabolites in biological matrices (plasma, serum, tissue).
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical trials.
• Metabolite Identification and Profiling: Aids in the structural elucidation and quantification of gemcitabine metabolites using isotope pattern recognition in mass spectrometry.
• Method Development and Validation: Critical for developing robust, regulatory-compliant (FDA, EMA) analytical methods with high specificity and minimal matrix effects.
• Drug-Drug Interaction Studies: Used in assays to investigate how co-administered drugs affect the metabolism and clearance of gemcitabine.
• Quality Control in Manufacturing: Can serve as a system suitability standard in the quality control of gemcitabine active pharmaceutical ingredient (API) and finished drug products.

Basic Information

Product Name	Gemcitabine-13C,15N2 Hydrochloride
CAS No.	1262897-74-4
Molecular Formula	C9H1113CF2N315N2O4 • HCl
Molecular Weight	Contact for details
Synonyms	2'-Deoxy-2',2'-difluoro-13C,15N2-cytidine Hydrochloride; 4-Amino-1-(2-deoxy-2,2-difluoro-13C,15N2-β-D-erythro-pentofuranosyl)-2(1H)-pyrimidinone Hydrochloride; dFdC-13C,15N2 HCl; Gemcitabine-13C,15N2 HCl; Isotopically Labeled Gemcitabine HCl; [13C,15N2]-Gemcitabine Hydrochloride
EINECS	Contact for details

Quality Control

Our Gemcitabine-13C,15N2 Hydrochloride is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing HPLC purity, isotopic enrichment, water content (KF), residual solvent analysis, and identity confirmation (NMR, MS). We adhere to relevant industry guidelines for reference standards to ensure data integrity in GLP/GMP-compliant environments.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, controlled environment. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation and moisture uptake.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to expected mass spectrum
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 99 atom % 13C; ≥ 99 atom % 15N
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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