Description

Buspirone Ep Impurity C is a high-purity reference standard critical for analytical method development and validation in pharmaceutical quality control. This compound is essential for ensuring the safety and efficacy of Buspirone hydrochloride, an anxiolytic medication, by accurately identifying and quantifying this specific enantiomeric impurity. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, quality assurance, and compliance testing. The reliable characterization of such impurities is fundamental to meeting stringent pharmacopeial standards for drug substance and finished product specifications.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the identification and quantification of Buspirone Ep Impurity C in Buspirone hydrochloride Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, linearity, accuracy, and limits of detection/quantification for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control of the impurity.
• Stability Studies: Used to track the formation and level of this specific enantiomeric impurity under various stress conditions and throughout the drug product's shelf life.
• Pharmacopeial Testing: Supports testing procedures aligned with United States Pharmacopeia (USP), European Pharmacopoeia (EP), and other international pharmacopeia monographs for Buspirone.

Basic Information

Product Name	Buspirone Ep Impurity C
CAS No.	257877-45-5
Molecular Formula	C21H31N5O2
Molecular Weight	385.50 g/mol
Synonyms	8-[4-[4-(2-Pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione Enantiomer; (R)-Buspirone Impurity C; Buspirone Enantiomeric Impurity C; Buspirone Related Compound C (Enantiomer); UNII-9F8S6A6D4C; 9F8S6A6D4C; Azapirone Impurity C
EINECS	Contact for details

Quality Control

Every batch of Buspirone Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, enantiomeric purity, and related substances. We support compliance with ICH, USP, and EP guidelines, and material can be supplied to meet custom specification requirements for research and regulatory purposes.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The container should be kept securely sealed in a cool, well-ventilated area away from incompatible materials.

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%
Enantiomeric Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual unknown 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.