Impurity reference standards
Raltegravir impurity standards
For Raltegravir, the Zemixal catalogue holds 20 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 6 pharmacopoeial impurities and 3 metabolites or hydroxylated analogues.
20reference materials
6pharmacopoeial
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. 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
Pharmacopoeial6EP, USP, BP or JP named impurities
Metabolites3Hydroxy, desmethyl and conjugated forms
Counts are based on product names. One compound can fall into more than one type.
All Raltegravir reference materials
1–20 of 20 standards
Methyl 2-((2-(4-((4-fluorobenzyl)carbamoyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidin-2-yl)propan-2-yl)amino)-2-oxoacetate
- CAS
- 518048-04-9
- Formula
- C19H21FN4O6
- MW
- 420.4 g/mol
ZX-022627
Methyl 2-(2-(((benzyloxy)carbonyl)amino)propan-2-yl)-5-hydroxy-6-oxo-1,6-dihydropyrimidine-4-carboxylate
- CAS
- 519032-08-7
- Formula
- C17H19N3O6
- MW
- 361.3 g/mol
ZX-026635
Questions
Raltegravir impurities, answered
What Raltegravir reference materials are available?
The catalogue currently lists 20 compounds for Raltegravir, including 6 pharmacopoeial impurities 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 Raltegravir 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 Raltegravir 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.