Description

Cyclohexanone Impurity 3 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 and fine chemicals. It is primarily utilized by pharmaceutical R&D laboratories, quality control (QC) departments, and analytical service providers for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in Cyclohexanone and related drug substances.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (HPLC, GC) for impurity detection.
• Quality Control and Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor and control impurity levels against established specifications.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity structure and purity for drug master files (DMFs).
• Research and Development (R&D): Used in chemical research to study degradation pathways, synthesis by-products, and the stability of Cyclohexanone-based compounds.
• Calibration of Analytical Instruments: Acts as a precise calibration standard to ensure the accuracy and reliability of spectroscopic and spectrometric equipment.

Basic Information

Product Name	Cyclohexanone Impurity 3
CAS No.	244230-63-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cyclohexanone Related Compound 3; Cyclohexanone Specified Impurity 3; Cyclohexanone EP Impurity C; Cyclohexanone USP Impurity; 2-Cyclohexen-1-one, 3-methyl- (possible isomer); 3-Methyl-2-cyclohexen-1-one; Potential process-related impurity of Cyclohexanone
EINECS	Contact for details

Quality Control

Our Cyclohexanone Impurity 3 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for reference standards. A comprehensive Certificate of Analysis (COA) detailing all test results and traceability is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term stability, consider storage under inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.