Description

Gepirone Impurity 1 (3-Hydroxy Gepirone) is a specified impurity and a key metabolite of the anxiolytic drug Gepirone. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control. It is primarily used by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical industry to ensure the purity, safety, and efficacy of Gepirone drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a primary standard for the identification and quantification of 3-Hydroxy Gepirone in Gepirone Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods (HPLC, UPLC) for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels, ensuring batch-to-batch consistency and compliance with regulatory specifications.
• Stability Studies: Used to track the formation of this degradant in Gepirone formulations under various stress conditions (e.g., heat, humidity, light).
• Metabolism and Pharmacokinetic Studies: Serves as a reference compound in ADME (Absorption, Distribution, Metabolism, and Excretion) research to understand the drug's metabolic pathway.
• Regulatory Submissions: Provides critical data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Gepirone Impurity 1 (3-Hydroxy Gepirone)
CAS No.	345894-78-2
Molecular Formula	C19H25N5O2
Molecular Weight	355.44 g/mol
Synonyms	3-Hydroxy Gepirone; 3-Hydroxy-4,4-dimethyl-1-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-2,6-piperazinedione; Gepirone Metabolite 1; Gepirone Related Compound A; 1-[4-[4-(Pyrimidin-2-yl)piperazin-1-yl]butyl]-3-hydroxy-4,4-dimethylpiperazine-2,6-dione; 3-Hydroxy-4,4-dimethyl-1-[4-[4-(pyrimidin-2-yl)piperazin-1-yl]butyl]piperazine-2,6-dione; Gepirone Impurity A
EINECS	Contact for details

Quality Control

Our Gepirone Impurity 1 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data, ensuring full traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines for reference 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) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.