Description

Gemcitabine Impurity 15 is a specified impurity associated with the active pharmaceutical ingredient Gemcitabine, an important nucleoside analog used in chemotherapy. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to monitor and control to ensure the safety, efficacy, and regulatory compliance of the final drug product. It is primarily used in analytical research and development, serving as a reference standard for method validation, stability studies, and quality control testing. Professionals in pharmaceutical quality assurance and regulatory affairs rely on high-purity impurity standards to meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Gemcitabine Impurity 15 in drug substances and products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control and Batch Release: Employed in routine QC testing to ensure impurity levels in active pharmaceutical ingredients (APIs) and finished dosage forms are within specified limits.
• Stability Studies: Used to monitor the formation of this impurity over time under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Submission and Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Gemcitabine during manufacturing and storage.

Basic Information

Product Name	Gemcitabine Impurity 15
CAS No.	294177-29-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	2'-Deoxy-2',2'-difluorocytidine Impurity 15; Gemcitabine Related Compound 15; Difluorodeoxycytidine Impurity 15; (2R,3R,4S,5R)-2-(4-Amino-2-oxopyrimidin-1(2H)-yl)-5-(hydroxymethyl)-3,4-difluorotetrahydrofuran-2-carboxylic acid (potential structure based on naming conventions); Gemcitabine Process Impurity; Gemcitabine Degradant; dFdC Impurity 15
EINECS	Contact for details

Quality Control

Every batch of Gemcitabine Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure identity, purity, and consistency, supporting compliance with ICH Q3A/B guidelines and pharmacopeial standards. Comprehensive characterization is performed using advanced techniques including HPLC, LC-MS, and NMR. A detailed Certificate of Analysis (COA) is provided with each batch, documenting all critical quality attributes. Certificates are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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