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Impurity reference standards

Meropenem impurity standards

7 characterised compounds linked to Meropenem are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 2 pharmacopoeial impurities and 1 metabolite or hydroxylated analogue.

7reference materials
2pharmacopoeial
1metabolites
Meropenem structure
Parent API

Meropenem

CAS
119478-56-7
Formula
C17H31N3O8S
MW
437.5 g/mol
Code
ZX-003932

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. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples.

By impurity type

Pharmacopoeial2EP, USP, BP or JP named impurities
Metabolites1Hydroxy, desmethyl and conjugated forms

Counts are based on product names. One compound can fall into more than one type.

All Meropenem reference materials

Questions

Meropenem impurities, answered

How many Meropenem impurity standards does Zemixal list?
The catalogue currently lists 7 compounds for Meropenem, including 2 pharmacopoeial impurities and 1 metabolite or hydroxylated analogue. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Meropenem 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 Meropenem 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.

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