Description

Finasteride Impurity C (Ep) is a specified impurity used in the quality control and analytical development of Finasteride, a key active pharmaceutical ingredient. This compound is critical for ensuring the purity, safety, and efficacy of Finasteride-based drug products by serving as a reference standard in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Primary use as a pharmaceutical reference standard for Finasteride impurity profiling.
• Critical component in analytical method development and validation (HPLC, LC-MS).
• Essential for conducting stability studies and determining degradation pathways of Finasteride.
• Used in quality control (QC) laboratories for the identification and quantification of impurities.
• Serves as a calibration standard to ensure the accuracy of analytical instruments.
• Supports regulatory filings and compliance with pharmacopoeial standards (e.g., USP, EP, ICH guidelines).
• Facilitates research and development of Finasteride synthesis and purification processes.

Basic Information

Product Name	Finasteride Impurity C (Ep)
CAS No.	1800205-94-0
Molecular Formula	C₂₃H₃₆N₂O₂
Molecular Weight	372.55 g/mol
Synonyms	Finasteride EP Impurity C; Finasteride Impurity C EP; (4aR,4bS,6aS,7S,9aS,9bS,11aR)-N-tert-Butyl-4a,6a-dimethyl-2-oxo-1,2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11-tetradecahydro-4H-indeno[5,4-f]quinoline-7-carboxamide; Finasteride Related Compound C (EP); Finasteride Impurity C (European Pharmacopoeia); 17β-(N-tert-Butylcarbamoyl)-4-aza-5α-androst-1-ene-3-one Impurity C
EINECS	Contact for details

Quality Control

Our Finasteride Impurity C (Ep) is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch is subjected to comprehensive testing, including identity confirmation by spectroscopic methods and purity determination by high-resolution chromatography. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopoeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term stability, consider storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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