Description

Piperazine Impurities CAS NO 2242625-36-9 is a high-purity reference standard critical for analytical research and quality control in pharmaceutical development. This compound is essential for the accurate identification, quantification, and monitoring of specific impurities in piperazine-based active pharmaceutical ingredients (APIs) and drug formulations. It is primarily used by research scientists and quality assurance professionals in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for method development and validation in impurity profiling.
• Analytical Research: Serves as a critical marker in HPLC, UPLC, and LC-MS analyses for quantifying related substances in piperazine drug substances.
• Quality Control (QC) & Quality Assurance (QA): Enables precise impurity tracking during API synthesis and final drug product release testing to meet ICH Q3A/B guidelines.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to monitor impurity formation and degradation pathways in stability testing of drug products and substances.
• Process Chemistry Optimization: Helps chemists identify and minimize the formation of specific by-products during manufacturing process development and scale-up.

Basic Information

Product Name	Piperazine Impurities
CAS No.	2242625-36-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Piperazine Related Compound; Piperazine Derivative Impurity; Piperazine Process Impurity; 1,4-Diazacyclohexane Impurity; Diethylenediamine Impurity; Hexahydropyrazine Impurity; CAS 2242625-36-9; Piperazine Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of our Piperazine Impurities is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profile testing using advanced chromatographic and spectroscopic techniques (e.g., HPLC, GC, NMR, MS) to ensure it meets the stringent requirements for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and handled under conditions that minimize exposure to ambient light and humidity to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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