Impurity reference standards
Mirtazapine impurity standards
Zemixal lists 20 reference materials related to Mirtazapine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 6 pharmacopoeial impurities, 1 isotope-labelled standard and 3 metabolites or hydroxylated analogues.
20reference materials
6pharmacopoeial
1isotope labelled
3metabolites
Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.
By impurity type
Pharmacopoeial6EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites3Hydroxy, desmethyl and conjugated forms
Counts are based on product names. One compound can fall into more than one type.
All Mirtazapine reference materials
1–20 of 20 standards
1-(3-Carboxy-2-pyridyl)-4-methyl-2-phenylpiperazine
- CAS
- 61338-13-4
- Formula
- C17H19N3O2
- MW
- 297.35 g/mol
ZX-022186
2-[(2-Hydroxyethyl)(methyl)amino]-1-phenylethan-1-ol
- CAS
- 23175-16-8
- Formula
- C11H17NO2
- MW
- 195.26 g/mol
ZX-025659
2-Chloro-N-(2-chloroethyl)-N-methyl-2-phenylethan-1-amine
- CAS
- 22270-22-0
- Formula
- C11H15Cl2N
- MW
- 232.15 g/mol
ZX-030660
Questions
Mirtazapine impurities, answered
How many Mirtazapine impurity standards does Zemixal list?
The catalogue currently lists 20 compounds for Mirtazapine, including 6 pharmacopoeial impurities, 1 isotope-labelled standard and 3 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Mirtazapine impurity standard?
A certificate of analysis travels with every lot. On request we share the characterisation set, usually 1H-NMR, mass spectrum, HPLC purity and IR, and for some materials TGA or water content. Ask for the data before ordering if your QA team needs to review it.
Can Zemixal make a Mirtazapine impurity that is not listed?
Often yes. Send the structure, name or CAS number with the quantity you need and our sourcing team checks custom synthesis options, usually from 10 mg up to gram scale, with a quoted lead time.
Are isotope-labelled Mirtazapine standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.