Description

Mirtazapine L-Tartaric Acid CAS NO 1705597-66-5 is a high-purity pharmaceutical salt form of the antidepressant mirtazapine, synthesized with L-tartaric acid to enhance its physicochemical properties for advanced drug formulation. This compound is critical for ensuring batch-to-batch consistency, bioavailability, and regulatory compliance in finished dosage forms. It is an essential active pharmaceutical ingredient (API) intermediate for pharmaceutical manufacturers and research institutions developing novel antidepressant therapies and controlled-release formulations.

Application

• Pharmaceutical API Synthesis: As a key salt intermediate in the commercial production of mirtazapine-based antidepressant medications.
• Generic Drug Manufacturing: For formulating bioequivalent generic versions of branded mirtazapine products.
• Controlled-Release Formulations: Used in research and development of extended-release tablets or capsules to improve patient compliance.
• Preclinical & Clinical Research: Serves as a reference standard and starting material for pharmacological studies and new drug application (NDA) submissions.
• Analytical Standard: For quality control laboratories to develop and validate HPLC, GC, or spectroscopic assay methods.
• Process Development & Scale-Up: For optimizing crystallization, purification, and manufacturing processes in pilot plants.

Basic Information

Product Name	Mirtazapine L-Tartaric Acid
CAS No.	1705597-66-5
Molecular Formula	C₁₇H₁₉N₃ • C₄H₆O₆
Molecular Weight	515.52 g/mol
Synonyms	Mirtazapine L-Tartrate; Mirtazapine (S,S)-Tartaric Acid Salt; Mirtazapine Hydrogen Tartrate; 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine L-Tartrate; Remeron L-Tartrate Salt; 6-Azamianserin L-Tartaric Acid Salt; Org 3770 L-Tartrate; Mirtazapine Tartaric Acid Co-crystal
EINECS	Contact for details

Quality Control

Our Mirtazapine L-Tartaric Acid is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical ingredient use. Each batch is tested to ensure identity, purity, and consistency. Certificates of Analysis (COA) documenting comprehensive testing against validated methods are provided with every shipment. We support compliance with ICH Q7 guidelines and relevant pharmacopeial standards (USP/EP) upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The material is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a low-humidity environment.

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)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 1.0%; Any single impurity ≤ 0.5%
Optical Rotation	Specific range available on COA

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