Description

10-Oxo Mirtazapine (Mirtazapine Impurity F) is a key pharmaceutical reference standard and impurity used in the development and quality control of the antidepressant drug Mirtazapine. This compound is critical for ensuring drug safety and efficacy by enabling the accurate identification, quantification, and control of related substances during manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and regulatory affairs teams focused on analytical method development and validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for calibrating analytical instruments and validating testing methods for Mirtazapine.
• Impurity Profiling and Control: Used to identify, quantify, and monitor the levels of Mirtazapine Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and analyze Mirtazapine and its related substances.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed as a marker to track impurity formation in Mirtazapine formulations under various stress and storage conditions.
• Pharmaceutical Research: Used in studies investigating the degradation pathways and metabolism of Mirtazapine.

Basic Information

Product Name	10-Oxo Mirtazapine (Mirtazapine Impurity F)
CAS No.	191546-97-1
Molecular Formula	C₁₇H₁₉N₃O
Molecular Weight	281.35 g/mol
Synonyms	Mirtazapine Impurity F; 10-Oxo-Mirtazapine; 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepin-10-one; 2-Methyl-1,2,3,4,10,14b-hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepin-10-one; Mirtazapine Related Compound F; Mirtazapine EP Impurity F; Mirtazapine USP Impurity F
EINECS	Contact for details

Quality Control

Our 10-Oxo Mirtazapine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for use as a pharmaceutical reference material. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality needs.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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 single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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