Active Pharmaceutical Ingredient

Mirtazapine

Also known as: Remeron; Avanza

CAS: 61337-67-5 NaSSA Antidepressant IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Mirtazapine API — Mediocon Inc
Mirtazapine — Pharmaceutical Grade API

Product Overview

CAS No: 61337-67-5  |  MF: C₁₇H₁₉N₃  |  MW: 265.36 g/mol

Mirtazapine is a pharmaceutical-grade active ingredient classified as NaSSA Antidepressant. Mediocon Inc supplies high-purity Mirtazapine API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

  • Noradrenergic and specific serotonergic antidepressant (NaSSA)
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Major depressive disorder
  • Anxiety disorders
  • Insomnia associated with depression

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameMirtazapine
Also Known AsRemeron; Avanza
CAS Number61337-67-5
Chemical Name1,2,3,4,10,14b-hexahydro-2-methyldibenzo[c,f]pyrazino[1,2-a]azepine
Molecular FormulaC₁₇H₁₉N₃
Molecular Weight265.36 g/mol
CategoryNaSSA Antidepressant
AppearanceWhite to off-white crystalline powder
SolubilitySlightly soluble in water
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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