Description

Buspirone Ep Impurity M is a high-purity reference standard used in the analytical profiling of the active pharmaceutical ingredient Buspirone. This compound is critical for pharmaceutical research and development, serving as a key marker for quality control and regulatory compliance. It is essential for laboratories in the pharmaceutical industry focused on method development, stability studies, and ensuring the purity and safety of Buspirone-based formulations.

Application

• Primary use as a certified reference standard for the identification and quantification of Buspirone impurities.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) for Buspirone API.
• Essential for conducting stability studies and forced degradation studies to monitor impurity profiles.
• Used in quality control laboratories to ensure batch-to-batch consistency and compliance with pharmacopoeial standards (USP, EP).
• Supports regulatory filings (e.g., ANDA, NDA) by providing impurity data for submission to health authorities like the FDA and EMA.
• Valuable for academic and institutional research into the metabolism and degradation pathways of Buspirone.

Basic Information

Product Name	Buspirone Ep Impurity M
CAS No.	80827-62-9
Molecular Formula	C21H31N5O2
Molecular Weight	385.51 g/mol
Synonyms	8-[4-[4-(2-Pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione; Buspirone Related Compound M; Buspirone Impurity M; Buspirone EP Impurity M; 8-[4-[4-(Pyrimidin-2-yl)piperazin-1-yl]butyl]-8-azaspiro[4.5]decane-7,9-dione; Azapirone Impurity M
EINECS	Contact for details

Quality Control

Our Buspirone Ep Impurity M is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles as determined by validated chromatographic methods (HPLC). We support compliance with ICH guidelines and pharmacopoeial requirements (USP, EP).

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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