Description

Milnacipran Impurity 3 is a specified organic compound used as a reference standard in analytical chemistry. This impurity is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Milnacipran HCl through rigorous chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control processes.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Milnacipran HCl drug substance and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating stability-indicating methods to monitor impurity profiles during drug development and manufacturing.
• Quality Control & Batch Release Testing: A critical component in the quality control workflow to ensure drug products meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (heat, light, humidity) to establish shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive understanding and control of the drug's impurity profile.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop robust purification processes for the API.

Basic Information

Product Name	Milnacipran Impurity 3
CAS No.	1353644-50-4
Molecular Formula	C15H22N2O
Molecular Weight	246.35 g/mol
Synonyms	(1R,2S)-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide; Milnacipran Related Compound C; F2695; 1-Phenylcyclopropanecarboxamide, 2-(aminomethyl)-N,N-diethyl-, (1R,2S)-; Milnacipran EP Impurity C; Milnacipran USP Impurity C
EINECS	Contact for details

Quality Control

Our Milnacipran Impurity 3 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analyses. The quality system is designed to support its use as a reference standard in GMP/GLP environments.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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