Description

Toremifene Impurity 4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Toremifene Citrate by serving as a key marker in impurity profiling. It is an essential material for pharmaceutical manufacturers, quality control laboratories, and research institutions engaged in method development, stability studies, and regulatory compliance. The precise characterization of this impurity is fundamental to meeting stringent pharmacopeial standards for pharmaceutical products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Toremifene Impurity 4 in drug substances and finished products.
• Analytical Method Development & Validation: Crucial for developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring product consistency and specification adherence.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Supports the preparation of regulatory dossiers for agencies like the FDA, EMA, and PMDA by providing necessary impurity characterization data.
• Research & Development: Facilitates studies on the synthesis pathway, degradation mechanisms, and metabolic pathways of Toremifene and related compounds.

Basic Information

Product Name	Toremifene Impurity 4
CAS No.	604010-60-8
Molecular Formula	C26H28ClNO
Molecular Weight	405.96 g/mol
Synonyms	4-[(Z)-4-Chloro-1,2-diphenyl-1-buten-1-yl]phenol; (Z)-4-(4-Chloro-1,2-diphenylbut-1-en-1-yl)phenol; Toremifene Related Compound C; Toremifene EP Impurity C; Toremifene USP Impurity C; FC-1A Metabolite; Metabolite FC-1A
EINECS	Contact for details

Quality Control

Every batch of Toremifene Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound 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 structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.