Description

Dutasteride Related Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Dutasteride through precise identification and quantification of impurities. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in drug development and quality control. The material is supplied with comprehensive analytical data to support method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Dutasteride API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, calibrate, and validate HPLC, UPLC, or GC methods for impurity profiling.
• Stability Studies: Employed to monitor the formation of this specific impurity during forced degradation and long-term stability testing of Dutasteride.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submissions (e.g., ANDA, NDA) by providing impurity identification and characterization data.
• Research & Development: Used in chemical research to study the degradation pathways and synthesis of Dutasteride and related compounds.
• Pharmacopoeial Testing: Serves as a system suitability and identification standard in compliance with USP, EP, or other pharmacopoeial monographs.

Basic Information

Item	Details
Product Name	Dutasteride Related Impurity 1
CAS No.	104214-61-1
Molecular Formula	C₂₇H₃₀F₆N₂O₂
Molecular Weight	528.53 g/mol
Synonyms	Dutasteride Impurity 1; (5α,17β)-N-{2,5 Bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide; Dutasteride EP Impurity A; Dutasteride USP Related Compound A; 4-Aza-5α-androst-1-en-3-one, 17β-[[[2,5-bis(trifluoromethyl)phenyl]amino]carbonyl]-; GSK 198,781 Impurity
EINECS	Contact for details

Quality Control

Every batch of Dutasteride Related Impurity 1 is manufactured and tested under strict quality management systems. The material undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results. Our quality standards are designed to meet the rigorous requirements of pharmaceutical reference material applications, supporting compliance with cGMP, ICH guidelines, and major pharmacopoeias (USP/EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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