Description

Buspirone Ep Impurity B is a specified impurity of the anxiolytic pharmaceutical agent Buspirone, identified by CAS NO 81461-73-6. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control testing of Buspirone drug substances and products. It is an essential material for regulatory compliance, ensuring the purity, safety, and efficacy of the final drug product. This impurity is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in the synthesis and quality assurance of Buspirone.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Buspirone Ep Impurity B in Buspirone Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Buspirone batches comply with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B) for specified impurities.
• Stability Studies: Used to track the formation and level of this impurity during forced degradation and long-term stability studies of Buspirone.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during Buspirone synthesis, helping to optimize manufacturing processes to minimize its generation.

Basic Information

Product Name	Buspirone Ep Impurity B
CAS No.	81461-73-6
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 B; Buspirone Impurity B; Buspirone EP Impurity B; 8-Azaspiro[4.5]decane-7,9-dione, 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-; UNII-8JQ5607IO5
EINECS	Contact for details

Quality Control

Our Buspirone Ep Impurity B is manufactured under strict quality control protocols to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Each lot undergoes comprehensive analytical characterization, including identification by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing the results against stringent in-house specifications aligned with ICH guidelines. Our quality system is designed to support regulatory requirements for pharmaceutical impurity standards.

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); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. 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 corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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