Description

Gimeracil Impurity CAS NO 149143-68-0 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 pharmaceutical products containing Gimeracil. It is primarily required by analytical laboratories and quality control units within the pharmaceutical and biotechnology industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Gimeracil and related drug substances.
• Analytical Method Development and Validation: Used as a critical standard to develop, validate, and verify HPLC, UPLC, and GC analytical methods for purity assays.
• Quality Control and Assurance (QC/QA): Essential for routine quality control testing in pharmaceutical manufacturing to monitor impurity levels and ensure batch-to-batch consistency.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurity specifications in drug master files (DMFs).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation and behavior of this specific impurity over time.
• Research and Development (R&D): Used in chemical and pharmacological research to study the properties, formation pathways, and potential effects of this impurity.

Basic Information

Product Name	Gimeracil Impurity
CAS No.	149143-68-0
Molecular Formula	C5H4N2O2
Molecular Weight	124.10 g/mol
Synonyms	5-Chloro-2,4(1H,3H)-pyrimidinedione; 5-Chlorouracil; 5-Chloro-2,4-dihydroxypyrimidine; 5-Chloro-1H-pyrimidine-2,4-dione; Gimeracil Related Compound; TS-1 Impurity; S-1 Impurity
EINECS	Contact for details

Quality Control

Every batch of Gimeracil Impurity (CAS 149143-68-0) is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including identity confirmation by spectroscopic methods (IR, NMR) and purity determination by validated chromatographic methods (HPLC). A Certificate of Analysis (COA) detailing batch-specific results is supplied with each product, ensuring traceability and compliance with ICH guidelines for impurities in pharmaceutical substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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