Description

1-Oxo Mirtazapine (Mirtazapine Impurity C) 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 manufacturers, analytical laboratories, and regulatory bodies for research, method validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the qualitative and quantitative analysis of Mirtazapine and its related substances.
• Impurity Profiling & Control: Essential for identifying and quantifying Mirtazapine Impurity C in active pharmaceutical ingredient (API) batches to meet ICH Q3A/B guidelines.
• Method Development & Validation: Serves as a critical component in developing and validating analytical methods, including HPLC, UPLC, and LC-MS.
• Stability Studies: Employed to monitor the formation of degradation products in Mirtazapine formulations under various stress conditions.
• Regulatory Compliance & Filing: Required for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity control.
• Quality Assurance/Quality Control (QA/QC): Used in routine quality control testing to ensure the purity and safety of the final drug product.

Basic Information

Product Name	1-Oxo Mirtazapine (Mirtazapine Impurity C)
CAS No.	191546-96-0
Molecular Formula	C₁₇H₁₉N₃O
Molecular Weight	281.35 g/mol
Synonyms	1-Oxo Mirtazapine; Mirtazapine Impurity C; Mirtazapine Related Compound C; 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepin-1-one; 2-Methyl-1,2,3,4,10,14b-hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepin-1-one; Mirtazapine N-Oxide Impurity; Mirtazapine EP Impurity C; Mirtazapine USP Impurity C
EINECS	Contact for details

Quality Control

Our 1-Oxo Mirtazapine is produced under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high purity and identity confirmation, aligning with pharmacopeial standards (USP/EP). A comprehensive Certificate of Analysis (COA) is provided, detailing results for assay, purity, and specified impurities.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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