Description

Milnacipran Impurity 4 is a designated impurity reference standard used in the pharmaceutical development and quality control of the antidepressant drug Milnacipran HCl. This high-purity compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of this specific impurity. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D, manufacturing, and contract testing laboratories.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Milnacipran Impurity 4 in active pharmaceutical ingredient (API) and finished drug product testing.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, to monitor impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Used in routine quality control laboratories to establish impurity profiles, set specifications, and ensure batch-to-batch consistency of Milnacipran HCl.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions (e.g., heat, light, humidity) to determine drug product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control and characterization.
• Research and Development: Supports synthetic route optimization and process chemistry studies to understand and minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Milnacipran Impurity 4
CAS No.	1353644-49-1
Molecular Formula	C15H22N2O
Molecular Weight	246.35 g/mol
Synonyms	(1R,2S)-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide; Milnacipran Related Compound 4; Milnacipran EP Impurity D; Milnacipran USP Impurity; F2695; 1-Phenyl-1-((1R,2S)-2-(diethylcarbamoyl)cyclopropyl)methanamine; (1R,2S)-rel-2-[(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide
EINECS	Contact for details

Quality Control

Every batch of Milnacipran Impurity 4 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept tightly sealed in a dry environment to prevent moisture absorption, which may affect stability and purity.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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