Description

Duloxetine Impurity 26 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) duloxetine hydrochloride. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by providing a reference for identification and quantification. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of duloxetine-based medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Duloxetine Impurity 26 in duloxetine API and finished dosage forms.
• Method Development and Validation: Crucial for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of duloxetine.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data and setting appropriate specification limits.
• Quality Control Testing: Employed in routine batch release testing of duloxetine API to ensure it meets the stringent purity requirements of pharmacopeial standards (USP, EP).
• Process Chemistry Research: Aids in the optimization of duloxetine synthesis and purification processes by tracking the formation and removal of this impurity.

Basic Information

Product Name	Duloxetine Impurity 26
CAS No.	741693-82-3
Molecular Formula	C18H19NOS
Molecular Weight	297.41 g/mol
Synonyms	(3S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine; (S)-N-Methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine; Duloxetine N-Methyl Impurity; Duloxetine Related Compound 26; 1-Naphthalenol, α-[(2S)-2-(methylamino)propyl]-2-thiophenemethanol; UNII-9J3H1B8V3R
EINECS	Contact for details

Quality Control

Every batch of Duloxetine Impurity 26 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive characterization and purity verification using advanced techniques including HPLC, GC, NMR, and MS to ensure it meets the exacting standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and chromatographic data is provided with each shipment to support your regulatory and QC needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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%

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