Description

Milnacipran Related Impurity 3 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antidepressant Milnacipran HCl. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and control of process-related impurities. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Milnacipran impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: A critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Facilitates research into the synthesis pathways, degradation mechanisms, and pharmacokinetics of Milnacipran and related compounds.

Basic Information

Item	Details
Product Name	Milnacipran Related Impurity 3
CAS No.	19532-98-0
Molecular Formula	C15H22N2O
Molecular Weight	246.35 g/mol
Synonyms	1-Phenyl-1-diethylaminocarbonyl-2-aminomethylcyclopropane; F 2207 Impurity; F 2207 Related Compound; Milnacipran Impurity C; (1RS,2SR)-2-[(Aminomethyl)-1-phenylcyclopropyl]-N,N-diethylcarboxamide; Milnacipran EP Impurity C; Milnacipran Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Milnacipran Related Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including identification (IR, NMR), assay (HPLC), and related substance analysis. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
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)	≤ 0.5% w/w

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