Description

Trifluridine Impurity CAS NO 2086328-10-9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antiviral drug Trifluridine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Trifluridine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels during manufacturing.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Trifluridine meets stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of this impurity over time under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Essential for preparing impurity data packages required for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Utilized in synthetic chemistry research to study degradation pathways and to develop purer synthetic processes for Trifluridine.

Basic Information

Item	Details
Product Name	Trifluridine Impurity
CAS No.	2086328-10-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Trifluridine Related Compound; Trifluridine Degradant; Trifluridine Process Impurity; Trifluridine Specified Impurity; 5-Trifluoromethyl-2'-deoxyuridine Impurity; FTD Impurity; Trifluorothymidine Impurity; TFT Impurity
EINECS	Contact for details

Quality Control

Every batch of Trifluridine Impurity CAS NO 2086328-10-9 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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 impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.