Description

Tipiracil Impurityjyj is a high-purity chemical reference standard, specifically identified as an impurity of the active pharmaceutical ingredient Tipiracil. This compound is critical for pharmaceutical research, development, and quality control processes, ensuring the safety and efficacy of final drug products. It is primarily utilized by analytical laboratories, quality assurance departments, and R&D teams within the global pharmaceutical and biotechnology industries for method validation and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify, quantify, and monitor Tipiracil Impurityjyj during API (Active Pharmaceutical Ingredient) development and manufacturing.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating sensitive HPLC, UPLC, or LC-MS methods to ensure accurate impurity detection.
• Quality Control and Batch Release Testing: Essential for routine QC testing of Tipiracil drug substance and drug products to confirm they meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Employed in forced degradation and long-term stability studies of Tipiracil to understand impurity formation pathways and shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity control and product safety.
• Academic and Contract Research: Supports research in synthetic chemistry, pharmacokinetics, and metabolite studies related to fluoropyrimidine-based therapeutics.

Basic Information

Product Name	Tipiracil Impurityjyj
CAS No.	733037-98-4
Molecular Formula	C15H19FN4O4
Molecular Weight	338.34 g/mol
Synonyms	5-Chloro-6-[(2-iminopyrrolidin-1-yl)methyl]-2,4(1H,3H)-pyrimidinedione; TAS-102 Impurity J; Trifluridine/Tipiracil Related Compound J; Tipiracil Related Substance J; 5-Chloro-6-((2-iminopyrrolidin-1-yl)methyl)pyrimidine-2,4(1H,3H)-dione; FTY Impurity J; (RS)-Tipiracil Impurity J
EINECS	Contact for details

Quality Control

Every batch of Tipiracil Impurityjyj CAS 733037-98-4 is manufactured and controlled under a strict quality management system. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) detailing purity, related substances, and residual solvents is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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