Description

Imp. E (Ep): 1,4-Bis(Diphenylmethyl)Piperazine is a high-purity pharmaceutical intermediate and reference standard. This compound is critical for ensuring the quality and safety of active pharmaceutical ingredients (APIs) by serving as a known impurity for analytical method development and validation. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on quality control, regulatory compliance, and process chemistry.

Application

• Pharmaceutical Impurity Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in API batches.
• Analytical Method Development: Essential for developing and validating HPLC, GC, or LC-MS methods in compliance with ICH guidelines.
• Quality Control (QC) & Assurance (QA): A key component in the impurity profile assessment of pharmaceutical products to meet EP, USP, and ICH regulatory requirements.
• Process Chemistry Research: Employed in studying reaction pathways, degradation products, and purification processes during API synthesis.
• Regulatory Submissions: Provides necessary impurity data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Imp. E (Ep): 1,4-Bis(Diphenylmethyl)Piperazine
CAS No.	216581-01-0
Molecular Formula	C30H30N2
Molecular Weight	418.57 g/mol
Synonyms	1,4-Bis(benzhydryl)piperazine; 1,4-Bis(diphenylmethyl)piperazine; Piperazine, 1,4-bis(diphenylmethyl)-; European Pharmacopoeia Impurity E; EP Impurity E; 1,4-Di(benzhydryl)piperazine; 1,4-Bis(α-phenylbenzyl)piperazine
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured under strict quality management systems. Every batch is characterized using advanced analytical techniques including NMR, HPLC, and mass spectrometry to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and traceability.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.