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Impurity reference standards

Milnacipran impurity standards

23 characterised compounds linked to Milnacipran are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 4 pharmacopoeial impurities, 1 isotope-labelled standard and 3 metabolites or hydroxylated analogues.

23reference materials
4pharmacopoeial
1isotope labelled
3metabolites

Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. 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

Pharmacopoeial4EP, 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 Milnacipran reference materials

1–23 of 23 standards
Questions

Milnacipran impurities, answered

How many Milnacipran impurity standards does Zemixal list?
The catalogue currently lists 23 compounds for Milnacipran, including 4 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 Milnacipran 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 Milnacipran 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 Milnacipran standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.
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