Description

Tipiracil Impurity Qjj is a high-purity reference standard used in the pharmaceutical development and quality control of Tipiracil, a key component in combination chemotherapy drugs. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and control during manufacturing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical method development and validation of Tipiracil API and its formulations.
• Quality Control & Assurance: Used in routine HPLC/LC-MS testing to monitor and control impurity levels in active pharmaceutical ingredient (API) batches to meet pharmacopeial specifications.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) as per ICH stability guidelines.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research & Development: Utilized in process chemistry R&D to understand impurity formation pathways and optimize synthesis routes for Tipiracil.

Basic Information

Product Name	Tipiracil Impurity Qjj
CAS No.	1815580-54-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tipiracil Related Compound Qjj; Tipiracil EP Impurity Qjj; Tipiracil USP Impurity Qjj; Tipiracil Degradant Qjj; Trifluridine/Tipiracil Impurity Qjj; TAS-102 Impurity Qjj; (5-Chloro-6-((2-iminopyrrolidin-1-yl)methyl)pyrimidine-2,4(1H,3H)-dione) related impurity; 1815580-54-1
EINECS	Contact for details

Quality Control

Every batch of Tipiracil Impurity Qjj is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity. The container should be kept tightly sealed after each use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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