Description

Gemcitabine Impurity 10 is a specified impurity of the antineoplastic agent Gemcitabine, identified by the CAS registry number 1147182-15-7. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical profiling and quality control of Gemcitabine drug substances and products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Gemcitabine active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Gemcitabine products meet specified purity limits as per ICH, USP, or EP guidelines.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Gemcitabine formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity characterization and control.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Gemcitabine to minimize the formation of this impurity.

Basic Information

Product Name	Gemcitabine Impurity 10
CAS No.	1147182-15-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Gemcitabine Related Compound 10; Gemcitabine EP Impurity J; Gemcitabine USP Impurity; 2'-Deoxy-2',2'-difluorocytidine Impurity; 4-Amino-1-((2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)pyrimidin-2(1H)-one related substance; Difluorodeoxycytidine Impurity; dFdC Impurity 10
EINECS	Contact for details

Quality Control

Every batch of Gemcitabine Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and compliance with industry standards. Certificates of Analysis (COA) detailing batch-specific results are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area.

Specification

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

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