Description

Dutasteride Impurity L is a high-purity chemical reference standard, specifically identified as a known impurity of the active pharmaceutical ingredient Dutasteride. This compound is critical for pharmaceutical research, development, and quality control processes, ensuring the safety and efficacy of the final drug product. It is primarily utilized by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, impurity profiling, and compliance testing.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Dutasteride drug substances and finished products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in GMP environments to monitor impurity levels.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Dutasteride.

Basic Information

Product Name	Dutasteride Impurity L
CAS No.	1365545-48-7
Molecular Formula	C27H30F6N2O2
Molecular Weight	528.53 g/mol
Synonyms	Dutasteride Related Compound L; Dutasteride EP Impurity L; Dutasteride USP Impurity L; (5α,17β)-N-{2,5-Bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide; 4-Azaandrost-1-ene-17-carboxamide, N-[2,5-bis(trifluoromethyl)phenyl]-3-oxo-, (5α,17β)-; Dutasteride Impurity 1 (according to some sources); Dutasteride Degradant L
EINECS	Contact for details

Quality Control

Every batch of Dutasteride Impurity L is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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