Description

Buspirone Hydrochloride Impurity D is a high-purity chemical reference standard critical for analytical and regulatory purposes in the pharmaceutical industry. This compound is essential for the identification, quantification, and control of a specific impurity during the manufacturing and quality assurance of Buspirone Hydrochloride, an anxiolytic medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Buspirone Hydrochloride drug substance and finished products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to monitor impurity levels against established specifications.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions and throughout the drug product's shelf life.
• Research and Development: Used in R&D laboratories to study impurity formation pathways, degradation chemistry, and to synthesize purer batches of the active pharmaceutical ingredient (API).

Basic Information

Product Name	Buspirone Hydrochloride Impurity D
CAS No.	2724726-67-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Buspirone HCl Impurity D; Buspirone Related Compound D; 8-[4-[4-(2-Pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione Hydrochloride Impurity; Buspirone Process Impurity D; Buspirone Degradant D; UNII-XXXX; (Potential IUPAC Name) Contact for details
EINECS	Contact for details

Quality Control

Every batch of Buspirone Hydrochloride Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic nature, the container should be kept in a dry environment and sealed immediately after use to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	90.0% - 110.0% (on dried basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5%; Total impurities: ≤ 2.0%

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