Description

Tipiracil Impurity 2 is a specified impurity associated with the active pharmaceutical ingredient Tipiracil, which is a key component in combination chemotherapy. This impurity is critical for pharmaceutical manufacturers to monitor and control to ensure the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by analytical laboratories and quality control departments in the pharmaceutical industry for method development, validation, and as a reference standard in stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Tipiracil drug substance and products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to separate and quantify this specific impurity.
• Quality Control & Batch Release Testing: Employed as a system suitability standard and for impurity profiling during the routine QC testing of Tipiracil API and finished dosage forms.
• Stability Studies & Forced Degradation: Used to identify and track the formation of this impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Utilized in R&D to understand the degradation pathways and chemistry of Tipiracil, aiding in process optimization.

Basic Information

Product Name	Tipiracil Impurity 2
CAS No.	2101241-71-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tipiracil Related Compound 2; Tipiracil EP Impurity 2; Tipiracil USP Impurity 2; Tipiracil Degradant; TAS-102 Impurity 2; 5-Chloro-6-[(2-iminopyrrolidin-1-yl)methyl]pyrimidine-2,4(1H,3H)-dione (Typical IUPAC); FT-207 Impurity (Related); Trifluridine/Tipiracil Impurity
EINECS	Contact for details

Quality Control

Every batch of Tipiracil Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including potential alignment with pharmacopeial monographs (USP, EP). Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles 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. The material may be hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single 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.