Description

Floxuridine Impurity CAS NO 77180-79-1 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Floxuridine. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Floxuridine drug substance and finished products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or GC methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Floxuridine APIs.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Floxuridine.
• Research & Development: Utilized in pharmaceutical R&D to study the degradation pathways, synthesis by-products, and metabolic pathways related to Floxuridine.

Basic Information

Product Name	Floxuridine Impurity
CAS No.	77180-79-1
Molecular Formula	C9H11FN2O5
Molecular Weight	246.19 g/mol
Synonyms	5-Fluoro-2'-deoxyuridine 5'-monophosphate; 5-Fluoro-2'-deoxyuridine 5'-(dihydrogen phosphate); 5-FdUMP; Floxuridine 5'-Monophosphate; Floxuridine 5'-Phosphate; 5-Fluoro-2'-deoxyuridylic acid; 2'-Deoxy-5-fluorouridine 5'-monophosphate; 5-Fluoro-dUMP
EINECS	Contact for details

Quality Control

Our Floxuridine Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) detailing all test results and specifications. The product is suitable for use under cGMP guidelines for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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