Description

Buspirone Ep Impurity E CAS NO 257877-46-6 is a specified impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Buspirone. This compound is critical for ensuring the purity, safety, and efficacy of Buspirone formulations by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of Buspirone Ep Impurity E in Buspirone API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC or UPLC methods to monitor impurity levels throughout the drug product lifecycle.
• Quality Control & Assurance (QC/QA): Serves as a primary standard in in-house quality control laboratories to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Compliance & Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Research & Development: Utilized in pharmaceutical R&D to understand the degradation pathways and chemistry of Buspirone.

Basic Information

Product Name	Buspirone Ep Impurity E
CAS No.	257877-46-6
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 E; Buspirone Impurity E; Buspirone EP Impurity E; 8-[4-[4-(Pyrimidin-2-yl)piperazin-1-yl]butyl]-8-azaspiro[4.5]decane-7,9-dione; Azapirone Impurity E
EINECS	Contact for details

Quality Control

Our Buspirone Ep Impurity E is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.