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Impurity reference standards

Sitagliptin impurity standards

Zemixal lists 94 reference materials related to Sitagliptin, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 6 pharmacopoeial impurities and 3 metabolites or hydroxylated analogues.

94reference materials
6pharmacopoeial
3metabolites
Sitagliptin structure
Parent API

Sitagliptin

CAS
486460-32-6
Formula
C16H15F6N5O
MW
407.31 g/mol
Code
ZX-004146

Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. 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
Metabolites3Hydroxy, desmethyl and conjugated forms

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

All Sitagliptin reference materials

1–60 of 94 standards
Questions

Sitagliptin impurities, answered

How many Sitagliptin impurity standards does Zemixal list?
The catalogue currently lists 94 compounds for Sitagliptin, 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 Sitagliptin 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 Sitagliptin 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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