Description

Milnacipran Impurity 12 is a designated impurity reference 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 benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Milnacipran Impurity 12 in drug substance and drug product analysis.
• Method Development & Validation: Essential for developing and validating stability-indicating HPLC or UPLC methods to monitor impurities during stability studies.
• Quality Control (QC) Testing: Employed in routine QC laboratories to confirm the impurity profile of Milnacipran API batches meets pharmacopeial (e.g., USP, EP) or internal specifications.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity data for drug master files.
• Stability Studies: Acts as a marker to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Utilized in pharmaceutical R&D to understand the degradation pathways and chemistry of Milnacipran.

Basic Information

Product Name	Milnacipran Impurity 12
CAS No.	153275-06-0
Molecular Formula	C15H20N2O
Molecular Weight	244.33 g/mol
Synonyms	(1R,2S)-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide; F 2207 Impurity; Milnacipran Related Compound 12; (1R,2S)-rel-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide; UNII-9F8V3W71QH; 9F8V3W71QH; 1-Phenylcyclopropanecarboxamide, 2-(aminomethyl)-N,N-diethyl-, (1R,2S)-rel-
EINECS	Contact for details

Quality Control

Every batch of Milnacipran Impurity 12 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and MS to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results for purity, related substances, residual solvents, 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). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown 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.