Description

Milnacipran Impurity 11 is a designated impurity standard used in the analytical profiling and quality control of the antidepressant drug Milnacipran HCl. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Milnacipran HCl API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure drug substance and product meet pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (forced degradation) and throughout shelf-life studies.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing impurity characterization data required by FDA, EMA, and other global health authorities.
• Process Chemistry Research: Aids in the optimization of synthetic routes by identifying and controlling the formation of specific process impurities.

Basic Information

Product Name	Milnacipran Impurity 11
CAS No.	1410831-12-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Milnacipran Related Compound 11; Milnacipran EP Impurity J; Milnacipran USP Impurity; (1R,2S)-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide Impurity; F2695 Impurity 11; Ixel Impurity 11; Savella Impurity 11
EINECS	Contact for details

Quality Control

Our Milnacipran Impurity 11 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC, MS, and NMR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring traceability and compliance with ICH guidelines and relevant pharmacopeial standards.

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 storing under inert atmosphere.

Specification

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

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