Description

Duloxetine Ep Impurity F (Oxalate) CAS NO 2379325-42-3 is a high-purity chemical reference standard specifically used for the analytical control of the active pharmaceutical ingredient, Duloxetine. This impurity is critical for ensuring the quality, safety, and efficacy of duloxetine-based drug products by enabling accurate identification and quantification during development and manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs teams focused on compliance with pharmacopeial standards like the European Pharmacopoeia (EP).

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify and quantify Duloxetine Ep Impurity F in drug substance and drug product batches.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure duloxetine API and finished dosage forms meet stringent pharmacopeial (EP, USP) and ICH regulatory specifications for impurities.
• Regulatory Submission and Compliance: Provides necessary data for regulatory filings (e.g., CMC sections of IND, NDA, ANDA) to demonstrate thorough impurity control strategies to agencies like the FDA and EMA.
• Pharmaceutical Research and Development: Used in synthetic route optimization and process chemistry to understand and minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Duloxetine Ep Impurity F (Oxalate)
CAS No.	2379325-42-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Duloxetine Related Compound F (Oxalate); (S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine Oxalate; Duloxetine Oxalate Impurity F; EP Impurity F of Duloxetine Oxalate; Duloxetine Process Impurity F; Duloxetine Oxalate Related Substance F
EINECS	Contact for details

Quality Control

Every batch of Duloxetine Ep Impurity F (Oxalate) is manufactured and controlled under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic techniques, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile, supporting your regulatory and quality assurance requirements.

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. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider conditions recommended for hygroscopic and light-sensitive pharmaceutical reference standards.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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