Description

Gimeracil Impurity CAS NO 17902-24-8 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 pharmaceutical manufacturers and contract research organizations (CROs) for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Gimeracil Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels in compliance with ICH Q3A/B guidelines.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and that impurity levels remain within specified safety thresholds.
• Stability Studies: Used to track the formation and growth of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Research and Development (R&D): Facilitates chemical research into the degradation pathways and synthesis of Gimeracil and related compounds.

Basic Information

Product Name	Gimeracil Impurity
CAS No.	17902-24-8
Molecular Formula	C5H4N2O2
Molecular Weight	124.10 g/mol
Synonyms	5-Chloro-2,4(1H,3H)-pyrimidinedione; 5-Chlorouracil; 5-Chloro-1H-pyrimidine-2,4-dione; 5-Chloro-2,4-dihydroxypyrimidine; NSC 74445; Gimeracil Related Compound; Gimeracil EP Impurity; Gimeracil USP Impurity
EINECS	Contact for details

Quality Control

Our Gimeracil Impurity is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch is subjected to comprehensive testing, including identity confirmation, purity assay, and impurity quantification. A detailed Certificate of Analysis (COA) is provided, which includes results from validated analytical methods such as HPLC, NMR, and MS. We support compliance with ICH guidelines and can supply material suitable for use under GMP settings for regulatory purposes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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