Description

Mirtazapine Bromide is a high-purity pharmaceutical intermediate and reference standard. This compound is critical for ensuring the quality, safety, and efficacy of active pharmaceutical ingredients (APIs) in the final drug product. It is primarily required by pharmaceutical manufacturers, research institutions, and quality control laboratories involved in the development and production of antidepressant medications.

Application

• Pharmaceutical Intermediate: A key building block in the synthesis of the antidepressant drug Mirtazapine.
• Reference Standard: Used in analytical laboratories for method development, validation, and routine quality control testing of APIs and finished dosage forms.
• Impurity Standard: Serves as a certified reference material for the identification and quantification of related substances in pharmaceutical products.
• Research & Development: Utilized in preclinical and clinical studies to understand pharmacokinetics, metabolism, and stability profiles.
• Process Development: Employed in optimizing and scaling up synthetic routes for commercial manufacturing.
• Regulatory Compliance: Essential for generating data to meet the stringent documentation requirements of global regulatory bodies like the FDA and EMA.

Basic Information

Product Name	Mirtazapine Bromide
CAS No.	61337-86-8
Molecular Formula	C₁₇H₁₉BrN₂
Molecular Weight	331.25 g/mol
Synonyms	1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine Bromide; 6-Azamianserin Bromide; Mirtazapine HBr; Org 3770 Bromide; Remeron Intermediate; 2-Methyl-1,2,3,4,10,14b-hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine Bromide
EINECS	Contact for details

Quality Control

Our Mirtazapine Bromide is manufactured under strict quality management systems. Every batch undergoes comprehensive analytical testing to ensure it meets the high-purity standards required for pharmaceutical applications. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting identity, purity, and impurity profiles. We adhere to cGMP principles where applicable to support our global clientele's regulatory 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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Individual impurity ≤0.5%; Total impurities ≤1.0%

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