Description

Buspirone Impurity 3 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Buspirone through precise identification and quantification of impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The reliable characterization of this impurity is essential for compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Buspirone Impurity 3 in Buspirone API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Buspirone drug substances and products meet ICH Q3A(R2) and pharmacopeial (USP, EP) impurity limits.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Supports synthetic chemistry research for process optimization and impurity fate and tolerance studies.

Basic Information

Product Name	Buspirone Impurity 3
CAS No.	872826-80-7
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 impurity; Buspirone Related Compound; Buspirone Process Impurity; Buspirone Degradant; 8-Azaspiro[4.5]decane-7,9-dione, 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-; Buspirone EP Impurity; Buspirone USP Impurity
EINECS	Contact for details

Quality Control

Our Buspirone Impurity 3 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is characterized using advanced techniques including HPLC, GC, NMR, and Mass Spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing the results against established specifications. Our quality system is designed to support GMP/GLP compliance for use in pharmaceutical development and regulatory applications.

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 must be kept under inert atmosphere or in a desiccator to maintain stability and purity. Avoid repeated or prolonged exposure to air.

Specification

Item	Specification
Appearance	White to off-white solid
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 unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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