Description

Gimeracil Impurity 7 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 utilized by research scientists and quality control professionals in the pharmaceutical and biotechnology industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Gimeracil and related drug substances.
• Analytical Method Development: Used to develop and validate sensitive HPLC, UPLC, or LC-MS methods for the detection and quantification of impurities.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies of pharmaceutical formulations.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Process Chemistry Research: Used in research to understand and control the formation of this impurity during the synthetic manufacturing process of Gimeracil.
• Academic & Contract Research: A vital tool for academic institutions and CROs (Contract Research Organizations) conducting pharmacological or metabolic studies.

Basic Information

Item	Details
Product Name	Gimeracil Impurity 7
CAS No.	1227600-22-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-Chloro-4-hydroxy-2(1H)-pyridinone; Gimeracil Related Compound 7; Gimeracil EP Impurity G; Gimeracil USP Impurity; TS-1 Impurity; S-1 Related Substance; 5-Chloro-4-hydroxypyridin-2(1H)-one; 5-Chloro-1,2-dihydro-4-hydroxypyridin-2-one
EINECS	Contact for details

Quality Control

Our Gimeracil Impurity 7 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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