Description

Imp. C (Ep): (4-(Diphenylmethyl)-1,1-Bis[(E)-3-Phenylprop-2-Enyl]Piperazinium Chloride is a high-purity pharmaceutical intermediate and reference standard critical for analytical method development and quality control in active pharmaceutical ingredient (API) manufacturing. This compound is essential for ensuring the identity, purity, and strength of related drug substances, directly impacting patient safety and regulatory compliance. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and manufacturers of complex organic molecules for use in method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in APIs.
• Analytical Method Development: Serves as a critical impurity marker in High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for method validation.
• Quality Control & Assurance: Employed in routine batch testing within pharmaceutical QC labs to monitor and control impurity levels according to pharmacopeial specifications (e.g., EP, USP).
• Process Chemistry Research: Used in R&D to study reaction pathways, optimize synthesis, and understand degradation profiles of pharmaceutical compounds.
• Regulatory Submissions: Provides essential data for drug master files (DMFs) and regulatory dossiers to demonstrate comprehensive impurity control strategies.

Basic Information

Product Name	Imp. C (Ep): (4-(Diphenylmethyl)-1,1-Bis[(E)-3-Phenylprop-2-Enyl]Piperazinium Chloride
CAS No.	95062-18-3
Molecular Formula	C35H37ClN2
Molecular Weight	521.13 g/mol
Synonyms	1,1-Bis[(E)-3-Phenylprop-2-enyl]-4-(diphenylmethyl)piperazin-1-ium Chloride; 4-(Diphenylmethyl)-1,1-bis(3-phenyl-2-propen-1-yl)piperazinium Chloride; Piperazinium, 4-(diphenylmethyl)-1,1-bis[3-phenyl-2-propen-1-yl]-, chloride; European Pharmacopoeia Impurity C; EP Impurity C
EINECS	Contact for details

Quality Control

Our Imp. C (Ep) is manufactured under strict quality management systems to meet the exacting standards required for pharmaceutical analysis. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, ensuring full traceability and compliance with relevant pharmacopeial guidelines. We are committed to supplying materials that support your regulatory requirements and quality benchmarks.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.