Description

Gemcitabine Impurity 12 is a specified impurity of the antineoplastic drug Gemcitabine, a critical component in pharmaceutical quality control and analytical research. This compound is essential for the development and validation of analytical methods to monitor and control impurity profiles in active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs professionals to ensure drug safety, efficacy, and compliance with stringent international pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Gemcitabine and related drug substances.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing of Gemcitabine API to ensure impurity levels remain within International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity identification and characterization.
• Stability Studies: Employed to monitor the formation of degradation products in Gemcitabine formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Gemcitabine.

Basic Information

Product Name	Gemcitabine Impurity 12
CAS No.	1932325-77-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Gemcitabine Related Compound 12; Gemcitabine EP Impurity J; Gemcitabine USP Impurity; 2'-Deoxy-2',2'-difluorocytidine Impurity 12; 4-Amino-1-((2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)pyrimidin-2(1H)-one related substance; dFdC Impurity 12; (2R,4R,5R)-4-Amino-1-(3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)pyrimidin-2(1H)-one impurity
EINECS	Contact for details

Quality Control

Our Gemcitabine Impurity 12 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) are provided, detailing batch-specific results for identity, purity, and impurity content. We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
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.