Description

Milnacipran Methyl Amine Impurity Hcl is a high-purity chemical reference standard, specifically identified as an impurity of the antidepressant drug Milnacipran Hydrochloride. This compound is critical for analytical research and development, enabling precise identification, quantification, and control of this specific impurity during pharmaceutical manufacturing. It is an essential material for quality control laboratories, analytical chemists, and R&D teams working in pharmaceutical development, regulatory compliance, and forensic analysis.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Milnacipran HCl and related substances.
• Method Development and Validation: Crucial for developing and validating sensitive analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control the levels of this specific impurity to ensure drug product safety and efficacy, complying with ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to track the formation of degradation impurities in Milnacipran formulations under various stress conditions.
• Academic and Clinical Research: Serves as a key reagent in studies investigating the metabolism, pharmacokinetics, and synthesis pathways of Milnacipran.

Basic Information

Product Name	Milnacipran Methyl Amine Impurity Hcl
CAS No.	165259-91-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-Phenyl-1-diethylaminocarbonyl-2-aminomethylcyclopropane hydrochloride; Milnacipran Impurity H; Milnacipran Related Compound H; F 2207 Impurity; (1RS,2SR)-2-[(Aminomethyl)-1-phenylcyclopropyl]-N,N-diethylcarboxamide hydrochloride
EINECS	Contact for details

Quality Control

Our Milnacipran Methyl Amine Impurity Hcl is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, NMR, and MS to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards, supporting compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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