Description

Duloxetine Impurity (n-Acetyl) is a key process-related impurity and degradation product of the widely prescribed antidepressant, Duloxetine Hydrochloride. This compound is critical for pharmaceutical manufacturers and analytical laboratories for method development, stability studies, and ensuring the purity and safety of the final drug product. It is primarily utilized by R&D scientists and quality control professionals in the pharmaceutical industry for comprehensive impurity profiling and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the n-Acetyl impurity in Duloxetine Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity levels throughout the drug's shelf life.
• Stability and Forced Degradation Studies: Employed to understand the degradation pathways of Duloxetine and to establish appropriate storage conditions and expiration dates.
• Quality Control & Batch Release Testing: Serves as a system suitability and qualification standard in routine QC testing to ensure every batch of API meets stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Submissions: Provides necessary data and impurity samples for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA and EMA to demonstrate thorough impurity control.
• Process Chemistry Research: Used by chemists to study and optimize the synthesis pathway of Duloxetine, aiming to minimize the formation of this specific impurity.

Basic Information

Product Name	Duloxetine Impurity (n-Acetyl)
CAS No.	1243540-90-0
Molecular Formula	C19H20NOS
Molecular Weight	310.44 g/mol
Synonyms	N-Acetyl Duloxetine; (S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)-N-(2-(acetyloxy)ethyl)propan-1-amine; Duloxetine N-Acetyl Impurity; Duloxetine Related Compound A (n-Acetyl); LY248686 N-Acetyl Derivative; (S)-N-Methyl-γ-(1-naphthalenyloxy)-2-thiophenepropanamine N-Acetyl Impurity
EINECS	Contact for details

Quality Control

Every batch of Duloxetine Impurity (n-Acetyl) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure it meets the high standards required for pharmaceutical analysis. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 must be kept in a desiccated environment to maintain stability and purity.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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