Description

Tipiracil Impurity Des Cl CAS NO 2069937-25-1 is a high-purity reference standard used for the analytical characterization and quality control of the active pharmaceutical ingredient (API) Tipiracil. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations containing Tipiracil. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and regulatory submissions.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Tipiracil API and its drug products.
• Essential for analytical method development and validation (HPLC, LC-MS) in quality control laboratories.
• Critical component in stability studies and forced degradation studies to monitor impurity profiles over time.
• Supports regulatory compliance for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Used in research and development to understand the degradation pathways and chemistry of Tipiracil.
• Serves as a calibration standard for ensuring the accuracy and precision of analytical instruments.

Basic Information

Product Name	Tipiracil Impurity Des Cl
CAS No.	2069937-25-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Des-Chloro Tipiracil Impurity; Tipiracil Des-Chloro Related Compound; Tipiracil EP Impurity; Tipiracil USP Impurity; Tipiracil Degradant; 5-Chloro-6-[(2-iminopyrrolidin-1-yl)methyl]pyrimidine-2,4(1H,3H)-dione derivative (Des-Cl); TAS-102 Impurity Des Cl
EINECS	Contact for details

Quality Control

This high-grade impurity standard is manufactured under strict quality control conditions suitable for pharmaceutical analysis. Each batch is characterized using advanced spectroscopic and chromatographic techniques to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters. Our quality system is designed to support GMP/GLP compliance for regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider conditions recommended for hygroscopic and light-sensitive compounds.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.