Description

Finasteride Impurity 11 is a specified impurity and a key reference standard used in the quality control of Finasteride, a widely prescribed pharmaceutical active ingredient. This compound is critical for ensuring the purity, safety, and efficacy of Finasteride drug substances and finished products through precise analytical methods. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Finasteride Impurity 11 in Finasteride Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Method Development and Validation: Essential for developing, validating, and transferring analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity profiles and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports impurity profiling, route scouting, and process chemistry optimization during Finasteride synthesis.

Basic Information

Product Name	Finasteride Impurity 11
CAS No.	104214-18-8
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 tert-Butyl Amide; Finasteride Related Compound B; Finasteride Impurity B; Finasteride EP Impurity B; Finasteride USP Related Compound B
EINECS	Contact for details

Quality Control

Every batch of Finasteride Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with relevant pharmacopeial standards and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for appearance, identification, assay (HPLC), related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C, in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 0.5%

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