Description

Piperazine Impurities CAS NO 2252258-81-2 refers to a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of pharmaceutical products containing piperazine derivatives by enabling the accurate identification and quantification of related substances. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical research, development, and manufacturing sectors.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Active Pharmaceutical Ingredients (APIs) and finished drug products containing piperazine cores.
• Method Development and Validation: Serves as a critical standard for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Mass Spectrometry (MS) protocols.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor batch-to-batch consistency and ensure impurity levels remain within International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used to track the formation of degradation products in piperazine-based pharmaceuticals under various stress conditions (e.g., heat, light, humidity).
• Chemical Research: Acts as a building block or intermediate in advanced chemical synthesis for researching new piperazine-derived compounds.

Basic Information

Product Name	Piperazine Impurities
CAS No.	2252258-81-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Piperazine Related Compound; Piperazine Derivative Impurity; Piperazine Analog; Specific Piperazine Impurity; Pharmaceutical Impurity Standard; Analytical Reference Standard; (Exact IUPAC name to be confirmed); Research Chemical 2252258-81-2
EINECS	Contact for details

Quality Control

This high-grade reference standard is manufactured under strict quality control conditions. Each batch is characterized using advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and MS, to confirm identity and purity. Certificates of Analysis (COA) are provided, detailing batch-specific results for purity, impurities, and other critical parameters. Our quality system is designed to support compliance with cGMP and relevant ICH Q3A/B guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment. For long-term stability, storage under an inert atmosphere is recommended.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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