Description

Dutasteride Chloro Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of Dutasteride, a medication primarily used to treat benign prostatic hyperplasia. This impurity is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in analytical testing. It is an essential material for research and development scientists, analytical chemists, and quality assurance professionals in the pharmaceutical industry who are involved in method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify and quantify the chloro impurity in Dutasteride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods.
• Quality Control and Assurance (QC/QA): Essential for routine batch release testing to ensure Dutasteride API and drug products meet stringent purity specifications as per ICH guidelines.
• Stability Studies: Employed to monitor the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., to FDA, EMA) to establish impurity thresholds and control strategies in accordance with ICH Q3A and Q3B.
• Research and Development: Used in synthetic chemistry research to understand the formation pathway of this impurity and to develop purer synthetic routes for Dutasteride.

Basic Information

Product Name	Dutasteride Chloro Impurity
CAS No.	1365545-42-1
Molecular Formula	C27H30F6N2O4S
Molecular Weight	592.60 g/mol
Synonyms	Dutasteride Chlorinated Impurity; Dutasteride Related Compound C; Dutasteride Chloro Analog; (5α,17β)-N-{2,5-Bis(trifluoromethyl)phenyl}-3-oxo-4-chloro-4-azaandrost-1-ene-17-carboxamide; 4-Chloro Dutasteride; Dutasteride Impurity C; Dutasteride Chloro Derivative; Dutasteride Chloro Related Substance
EINECS	Contact for details

Quality Control

Our Dutasteride Chloro Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting compliance with current Good Manufacturing Practice (cGMP) and ICH regulatory guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.