Description

Dutasteride 17 Alpha Epimer CAS NO 2102935-76-0 is a specific stereoisomer of the pharmaceutical compound dutasteride, a potent 5-α-reductase inhibitor. This high-purity reference standard is critical for analytical research, method development, and quality control in pharmaceutical manufacturing. It is primarily required by research institutions, analytical laboratories, and API producers for impurity profiling, stability studies, and ensuring the stereochemical purity of active pharmaceutical ingredients.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the 17-alpha epimer impurity in dutasteride drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to separate and analyze dutasteride stereoisomers.
• Impurity Profiling & Control: Serves as a key impurity marker in stability-indicating assays and for establishing specification limits in accordance with ICH Q3A and Q3B guidelines.
• Pharmacological & Metabolic Studies: Utilized in research to study the biological activity, metabolism, and pharmacokinetics of dutasteride's different stereoisomers.
• Quality Control (QC) & Quality Assurance (QA): A critical tool for in-house QC testing to ensure batch-to-batch consistency and compliance with regulatory filings for dutasteride-based medications.
• Regulatory Submission Support: Provides essential data and characterization for regulatory documentation required by agencies like the FDA and EMA.

Basic Information

Item	Detail
Product Name	Dutasteride 17 Alpha Epimer
CAS No.	2102935-76-0
Molecular Formula	C₂₇H₃₀F₆N₂O₂
Molecular Weight	528.53 g/mol
Synonyms	(5α,17β)-N-{2,5-Bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide; Dutasteride Impurity F (EP); Dutasteride EP Impurity F; Dutasteride Related Compound F; 17-Epi Dutasteride; 17α-Dutasteride; Avodart Impurity F; GG745 Epimer
EINECS	Contact for details

Quality Control

Our Dutasteride 17 Alpha Epimer is manufactured under strict quality systems. Each batch is characterized and tested to ensure high chemical and stereochemical purity, meeting the stringent requirements for pharmaceutical reference standards. Comprehensive analytical data, including HPLC purity, chiral purity, and structural confirmation (NMR, MS), is provided. A Certificate of Analysis (COA) with batch-specific results is available for every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0% (as 17-alpha epimer)
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
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.