Description

Finasteride Impurity 14 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of Finasteride, a widely prescribed active pharmaceutical ingredient. It serves as an essential tool for scientists and quality assurance professionals in the pharmaceutical and fine chemical industries who require precise impurity profiling to ensure drug safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Finasteride drug substances and finished products.
• Analytical Method Development & Validation: A critical component for developing, optimizing, and validating HPLC, UPLC, and GC analytical methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing definitive impurity data for stability studies and specification setting.
• Stability Testing & Forced Degradation Studies: Used to monitor the formation of this specific impurity under various stress conditions (light, heat, humidity) to establish product shelf-life.
• Process Chemistry & Optimization: Assists chemical engineers and process chemists in monitoring and minimizing the formation of this impurity during Finasteride synthesis and purification steps.
• Academic & Contract Research: Serves as a research-grade chemical for universities and CROs (Contract Research Organizations) conducting studies on Finasteride metabolism, degradation pathways, or novel analytical techniques.

Basic Information

Product Name	Finasteride Impurity 14
CAS No.	140375-21-9
Molecular Formula	C23H36N2O2
Molecular Weight	372.55 g/mol
Synonyms	N-(1,1-Dimethylethyl)-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide; Finasteride Related Compound; Finasteride EP Impurity; Finasteride USP Impurity; 17β-(tert-Butylcarbamoyl)-4-aza-5α-androst-1-en-3-one; 4-Azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-, (5α,17β)-; Finasteride Degradant
EINECS	Contact for details

Quality Control

Every batch of Finasteride Impurity 14 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, test methods, and acceptance criteria.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term stability, consider storage under inert atmosphere at -20°C.

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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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