Description

Gemcitabine Impurity 9 CAS NO 2174019-90-8 is a high-purity reference standard used for the identification, qualification, and quantification of a specific process-related impurity in the active pharmaceutical ingredient (API) Gemcitabine. This compound is critical for ensuring the quality, safety, and efficacy of the final drug product by enabling precise analytical control during manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs teams involved in the development and production of Gemcitabine-based chemotherapeutic agents.

Application

• Primary use as a certified reference standard for analytical method development and validation in pharmaceutical quality control.
• Identification and quantification of specified impurity in Gemcitabine API batches according to ICH Q3A/B guidelines.
• Critical component in stability studies to monitor impurity profiles over the drug product's shelf life.
• Used for regulatory submissions (e.g., to FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Essential for in-house pharmacopeial testing to comply with USP/EP monograph requirements for Gemcitabine.
• Supports process chemistry research to understand and mitigate impurity formation during API synthesis.

Basic Information

Product Name	Gemcitabine Impurity 9
CAS No.	2174019-90-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Gemcitabine Related Compound 9; Gemcitabine EP Impurity 9; Gemcitabine USP Impurity 9; 2'-Deoxy-2',2'-difluorocytidine Impurity 9; dFdC Impurity 9; (2R,3R,4S,5R)-2-(4-Amino-2-oxopyrimidin-1(2H)-yl)-5-((((R)-1-(2-((tert-butyldimethylsilyl)oxy)ethyl)-2-((tert-butyldimethylsilyl)oxy)ethoxy)hydroxyphosphoryl)oxy)methyl)-4-fluorotetrahydrofuran-3-yl (2,2-dimethylpropanoyl)formate
EINECS	Contact for details

Quality Control

Every batch of Gemcitabine Impurity 9 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (NMR, IR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). Certificates of Analysis (COA) are available upon request, providing full traceability and detailed analytical results.

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 indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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