Mirtazapine Related Compounds & Impurities

Mirtazapine is a noradrenergic and specific serotonergic antidepressant (NaSSA) with H1 antihistaminic sedative effects, used for major depression.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Mirtazapine reference standards, pharmacopeial and non-pharmacopeial Mirtazapine impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Mirtazapine-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Mirtazapine
Mirtazapine EP Impurity A
Mirtazapine EP Impurity B
Mirtazapine EP Impurity C
Mirtazapine EP Impurity D
4-Methyl-1-(3-methyl-2-pyridinyl)-2-phenylpiperazine
Mirtazapine Carboxylic Acid
Mirtazapine Intermediate 1
Mirtazapine EP Impurity E
Mirtazapine EP Imp F (USP RC D)
Mirtazapine Cyano Impurity
2-Chloro-3-pyridinecarbonitrile
Mirtazapine Cyano Impurity
8-Hydroxy Mirtazapine
Mirtazapine Impurity 4
1,2,3,4,10,14b-Hexahydrobenzo[c]pyrazino[1,2-a]pyrido[3,2-f]azepine maleate
Mirtazapine Impurity 3
Mirtazapine Impurity 1
Mirtazapine Related Compound B
Mirtazapine Impurity 5
N-Nitroso Mirtazapine EP Impurity D
Mirtazapine Carbonitrile Oxalate
Mirtazapine EP Impurity D Hydrochloride
Mirtazapine Nitroso Impurity 2
N Nitroso N Desmethyl Mirtazapine EP Impurity B
N-Nitroso N-Desmethyl Mirtazapine EP Impurity E
N-Nitroso N-Desmethyl Mirtazapine EP Impurity F
Mirtazapine Nitroso Impurity 1
Mirtazapine Impurity 2
8-Hydroxy Mirtazapine Beta-D-Glucuronide
Mirtazapine Related Compound C
Mirtazapine Related Compound A
Mirtazapine Nitroso Impurity 3

Metabolites

Mirtazapine N-Beta-Glucuronide Diastereomer A

Isotope Labelled Compounds

Mirtazapine-D4
Desmethylmirtazapine D4
Mirtazapine-13C,D3 Hydrochloride
Mirtazapine-D4 DiHydrochloride
N-Desmethyl Mirtazapine-D4-Hydrochoride
Mirtazapine D3
S-Mirtazapine D3