Description

Buspirone Impurity 1 (Lactone Of 6-Hydroxy Buspirone) is a specified impurity and degradation product of the anxiolytic pharmaceutical agent Buspirone. This compound is critical for analytical method development, stability studies, and quality control in pharmaceutical manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and manufacturers of active pharmaceutical ingredients (APIs) and finished dosage forms to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Buspirone Impurity 1 in Buspirone API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability and Forced Degradation Studies: Employed to understand the degradation pathways of Buspirone and to establish appropriate storage conditions and shelf-life.
• Quality Control & Batch Release Testing: Serves as a system suitability standard and for setting impurity acceptance criteria in accordance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data on impurity characterization and control strategies for drug master files (DMFs), ANDAs, and INDs submitted to agencies like the FDA and EMA.
• Pharmacopoeial Testing: Used in testing to meet the specifications of pharmacopoeias such as USP, EP, or BP for Buspirone monographs.

Basic Information

Product Name	Buspirone Impurity 1 (Lactone Of 6-Hydroxy Buspirone)
CAS No.	125498-83-1
Molecular Formula	C21H31N5O2
Molecular Weight	385.51 g/mol
Synonyms	6-Hydroxybuspirone Lactone; 8-[4-[4-(2-Pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione; Buspirone Lactone Impurity; Buspirone Related Compound A (in some contexts); UNII-9F8S6A6D4C; Azapirone impurity; 8-Azaspiro[4.5]decane-7,9-dione, 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-
EINECS	Contact for details

Quality Control

Our Buspirone Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to primary standards where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The container should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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