Description

Duloxetine Impurity A is a specified impurity of the active pharmaceutical ingredient (API) Duloxetine Hydrochloride, used in the treatment of major depressive disorder and other conditions. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, ensuring the safety and efficacy of the final drug product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Duloxetine API and its formulations.
• Impurity Profiling & Identification: Essential for identifying, characterizing, and quantifying this specific impurity during drug substance and drug product development.
• Method Development & Validation (HPLC/LC-MS): Serves as a critical component in developing and validating analytical methods for purity and stability-indicating assays.
• Stability Studies: Used to monitor the formation of this impurity over time under various stress conditions (e.g., heat, light, humidity) to establish shelf life.
• Regulatory Compliance & Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity levels and control strategies.
• Quality Control (QC) Testing: Employed in routine QC testing of Duloxetine batches to ensure they meet stringent pharmacopeial (e.g., USP, EP) impurity limits.

Basic Information

Product Name	Duloxetine Impurity A
CAS No.	947686-09-1
Molecular Formula	C18H19NOS
Molecular Weight	297.41 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 Related Compound A; Duloxetine EP Impurity A; Duloxetine USP Impurity A; (S)-Duloxetine N-Methyl Impurity
EINECS	Contact for details

Quality Control

Every batch of Duloxetine Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. 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 at controlled room temperature (15-25°C) or as indicated on the label or COA. This compound is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.