Description

Duloxetine Impurity 20 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 pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily used by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Duloxetine Impurity 20 in Duloxetine 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 profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure API batches comply with stringent pharmacopeial (USP, EP, ICH) limits for specified impurities.
• Stability Studies: Employed to track the formation of this impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Duloxetine to minimize the formation of this specific impurity.

Basic Information

Product Name	Duloxetine Impurity 20
CAS No.	14994-02-6
Molecular Formula	C18H19NOS
Molecular Weight	297.42 g/mol
Synonyms	(S)-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 Analog; Duloxetine EP Impurity I; Duloxetine Related Compound I; Thiophene Naphthalene Derivative; LY 248686 Impurity
EINECS	Contact for details

Quality Control

Every batch of Duloxetine Impurity 20 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available for regulatory review.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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 desiccant use.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C
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.