Description

Buspirone Ep Impurity B CAS NO 179071-85-3 is a high-purity reference standard specifically used in the analytical profiling of the active pharmaceutical ingredient (API) Buspirone. This compound is critical for ensuring the quality, safety, and efficacy of Buspirone-based pharmaceutical formulations by serving as a key marker for impurity identification and quantification. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development, validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Buspirone Ep Impurity B in Buspirone API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods for Buspirone.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels and ensure batches comply with International Conference on Harmonisation (ICH) guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Employed as a benchmark to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA and EMA.
• Research on Degradation Pathways: Aids in understanding the degradation mechanisms of Buspirone, helping to improve formulation stability and shelf-life.

Basic Information

Product Name	Buspirone Ep Impurity B
CAS No.	179071-85-3
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 Impurity B; Buspirone Related Compound B; Buspirone EP Impurity B; 8-[4-[4-(Pyrimidin-2-yl)piperazin-1-yl]butyl]-8-azaspiro[4.5]decane-7,9-dione; Azapirone Impurity; Spiro[4.5]decane-7,9-dione derivative
EINECS	Contact for details

Quality Control

Every batch of Buspirone Ep Impurity B is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive analytical characterization using techniques including HPLC, GC, NMR, and MS to confirm identity and ensure high purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. Our quality commitment supports your regulatory needs for GMP/GLP environments.

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); ensure the container is kept tightly sealed in a low-humidity environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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 unspecified 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.