Description

Finasteride Impurity C CAS NO 1329611-51-9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Finasteride, a widely used active pharmaceutical ingredient. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Finasteride Impurity C in Finasteride drug substance and finished products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity profiles and stability data required by agencies like the FDA and EMA.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation in Finasteride formulations.
• Research & Development: Used in R&D for studying the degradation pathways and metabolism of Finasteride.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability and calibration standard for routine batch release testing in pharmaceutical manufacturing.

Basic Information

Product Name	Finasteride Impurity C
CAS No.	1329611-51-9
Molecular Formula	C23H36N2O2
Molecular Weight	372.55 g/mol
Synonyms	N-(1,1-Dimethylethyl)-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide; 17β-(tert-Butylcarbamoyl)-4-aza-5α-androst-1-en-3-one; Finasteride Impurity 3; Finasteride Related Compound C; 4-Azaandrost-1-ene-3-one-17β-carboxylic acid tert-butylamide; Finasteride Degradant
EINECS	Contact for details

Quality Control

Our Finasteride Impurity C is manufactured under strict quality systems to meet the exacting standards of the pharmaceutical industry. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure compliance with pharmacopeial guidelines. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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