Description

Clofazimine Iminophenazine Impurity 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 the active pharmaceutical ingredient, Clofazimine, by serving as a known impurity marker. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling. The precise characterization of this impurity is fundamental to meeting stringent pharmacopeial standards for drug substances.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of related substances in Clofazimine API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance and Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization.
• Research and Development: Utilized in synthetic chemistry research to study the degradation pathways and metabolism of Clofazimine.

Basic Information

Product Name	Clofazimine Iminophenazine Impurity
CAS No.	1332634-93-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Clofazimine Impurity; Clofazimine Related Compound; Iminophenazine Impurity of Clofazimine; 3-(4-Chloroanilino)-10-(4-chlorophenyl)-2,10-dihydro-2-(isopropylimino)phenazine; LM 675 Impurity; B-663 Impurity; Lamprene Impurity
EINECS	Contact for details

Quality Control

Our Clofazimine Iminophenazine Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability. We support compliance with ICH Q3A/B, USP, and EP guidelines.

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 desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	Off-white to yellow solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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