Description

Dutasteride Impurity E (Dutasteride 17-Alfa-Epimer) is a high-purity reference standard and a critical stereoisomeric impurity of the active pharmaceutical ingredient Dutasteride. This compound is essential for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of the 17-Alpha epimer during the manufacturing process. It is primarily used by analytical laboratories, quality assurance departments, and R&D teams in the pharmaceutical industry to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the calibration of analytical instruments and the validation of testing methods.
• Method Development & Validation: Used in developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling of Dutasteride.
• Quality Control & Assurance: Critical for establishing impurity thresholds, conducting stability studies, and ensuring batch-to-batch consistency in API manufacturing.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Research on Degradation Pathways: Aids in studying the stability and potential degradation routes of Dutasteride under various conditions.

Basic Information

Product Name	Dutasteride Impurity E (Dutasteride 17-Alfa-Epimer)
CAS No.	1796930-46-5
Molecular Formula	C27H30F6N2O2
Molecular Weight	528.54 g/mol
Synonyms	Dutasteride 17-Alpha Epimer; Dutasteride EP Impurity E; Dutasteride Related Compound E; (5α,17β)-N-{2,5-bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide; 17-Epi Dutasteride; Avodart Impurity E; GG745 Impurity E
EINECS	Contact for details

Quality Control

Our Dutasteride Impurity E is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, chiral purity determination, and identity confirmation (IR, MS), to ensure it meets the stringent requirements for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The compound is light-sensitive (store away from light).

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%
Chiral Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
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.