Description

Desmethyl-6,8,10-Triene Dutasteride is a key synthetic intermediate and impurity reference standard used in the production and quality control of the active pharmaceutical ingredient dutasteride. This compound is critical for ensuring the purity, safety, and efficacy of final pharmaceutical formulations targeting benign prostatic hyperplasia (BPH). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in the development and strict quality assurance of 5-α-reductase inhibitor therapies.

Application

• Pharmaceutical Intermediate: A crucial building block in the multi-step synthesis of the active pharmaceutical ingredient (API) Dutasteride.
• Analytical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances and process impurities in Dutasteride API and finished dosage forms via HPLC, LC-MS, and other chromatographic methods.
• Quality Control & Assurance: Essential for establishing and validating analytical methods, ensuring batch-to-batch consistency and compliance with pharmacopeial standards (USP, EP).
• Process Development & Optimization: Employed in research to study synthetic pathways, optimize reaction conditions, and improve the overall yield and purity of the final API.
• Regulatory Compliance: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity profiles for drug master files (DMFs).
• Metabolic and Pharmacokinetic Studies: Used in research to investigate the metabolic pathways and stability of dutasteride-related compounds.

Basic Information

Product Name	Desmethyl-6,8,10-Triene Dutasteride
CAS No.	952718-75-1
Molecular Formula	C₂₇H₃₀F₆N₂O₂
Molecular Weight	528.53 g/mol
Synonyms	Desmethyl-6,8,10-Triene Dutasteride; (5α,17β)-N-{2,5-Bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrosta-1,6,8,10-tetraene-17-carboxamide; Dutasteride Impurity; Dutasteride Related Compound; 4-Aza-5α-androsta-1,6,8,10-tetraene-3-one-17β-carboxamide derivative; GG 745 Impurity; Avodart Impurity
EINECS	Contact for details

Quality Control

Our Desmethyl-6,8,10-Triene Dutasteride is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical development and analysis. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The compound is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.