Description

Buspirone Impurity E is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the identification, qualification, and control of impurities in Buspirone hydrochloride active pharmaceutical ingredient (API) and finished drug products. It is primarily used by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and contract research organization (CRO) sectors to ensure product safety, efficacy, and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of Buspirone and its related substances.
• Method Development and Validation: Used in developing and validating robust analytical methods, primarily High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS), for impurity profiling.
• Quality Control and Assurance: Employed in routine QC testing to monitor and control the level of this specific impurity during API synthesis and drug formulation to meet ICH Q3A/B guidelines.
• Regulatory Submission and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Buspirone.
• Research and Development: Facilitates process chemistry optimization by helping to identify and eliminate the source of this impurity during synthesis.

Basic Information

Item	Details
Product Name	Buspirone Impurity E
CAS No.	257877-43-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	8-[4-[4-(2-Pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione; Buspirone Related Compound E; Buspirone EP Impurity E; Buspirone USP Impurity E; Azaperone Impurity; Potential degradation product of Buspirone
EINECS	Contact for details

Quality Control

Every batch of Buspirone Impurity E is manufactured and handled under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards (USP/EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle the material in accordance with good laboratory practices to prevent contamination.

Specification

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

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