Description

Dutasteride Ep Impurity I CAS NO 1648593-70-7 is a high-purity reference standard specifically used in the analytical profiling and quality control of the active pharmaceutical ingredient, Dutasteride. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential tool for research and development, method validation, and routine batch testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Dutasteride API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and GC analytical methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for in-process testing and release testing of Dutasteride batches to meet pharmacopeial standards (USP, EP, ICH).
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Dutasteride formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry research to understand and control impurity formation during the manufacturing process of Dutasteride.

Basic Information

Item	Detail
Product Name	Dutasteride Ep Impurity I
CAS No.	1648593-70-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dutasteride Impurity I; Dutasteride EP Impurity I; Dutasteride Related Compound I; (5α,17β)-N-{2,5-Bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide; 4-Aza-5α-androst-1-en-3-one, 17β-({[2,5-bis(trifluoromethyl)phenyl]amino}carbonyl)-; Dutasteride Impurity A (EP); Dutasteride Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Dutasteride Ep Impurity I is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and mass spectrometry to ensure compliance with pharmacopeial standards (EP, USP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to guarantee traceability and reliability for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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