(2R)-1-(Chloroacetyl)-2-pyrrolidinecarbonitrile
- CAS
- 565452-98-4
- Formula
- C7H9ClN2O
- MW
- 172.61 g/mol
ZX-022384
Impurity reference standards
Vildagliptin impurity standards
This page brings together 33 Vildagliptin related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 1 pharmacopoeial impurity, 3 nitrosamines and 4 metabolites or hydroxylated analogues.
33reference materials
1pharmacopoeial
3nitrosamines
4metabolites
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. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.
By impurity type
Pharmacopoeial1EP, USP, BP or JP named impurities
Nitrosamines3N-nitroso impurities for ICH M7 work
Metabolites4Hydroxy, desmethyl and conjugated forms
Counts are based on product names. One compound can fall into more than one type.
All Vildagliptin reference materials
1–33 of 33 standards
(2S,2'S)-1,1'-[[(3-Hydroxytricyclo[3.3.1.13,7]dec-1-yl)imino]bis(1-oxo-2,1-ethanediyl)]bis-2-pyrrolidinecarbonitrile
- CAS
- 1036959-23-5
- Formula
- C24H33N5O3
- MW
- 439.6 g/mol
ZX-023025
(2S)-1-(Chloroacetyl)-2-pyrrolidinecarbonitrile
- CAS
- 207557-35-5
- Formula
- C7H9ClN2O
- MW
- 172.61 g/mol
ZX-023027
(2S)-1-Dichloroacetyl-2-pyrrolidinecarbonitrile
- CAS
- 1803168-09-3
- Formula
- C7H8Cl2N2O
- MW
- 207.05 g/mol
ZX-027589
(S)-1-(2-Hydroxyacetyl)pyrrolidine-2-carboxamide
- CAS
- 96166-39-1
- Formula
- C7H12N2O3
- MW
- 172.18 g/mol
ZX-027583
(S)-1-(tert-Butoxycarbonyl)-2-cyanopyrrolidine
- CAS
- 228244-04-0
- Formula
- C10H16N2O2
- MW
- 196.25 g/mol
ZX-034310
2,6-Di-tert-butyl-4-hydroxy-4-methyl-2,5-cyclohexadien-1-one
- CAS
- 10396-80-2
- Formula
- C15H24O2
- MW
- 236.35 g/mol
ZX-036385
Questions
Vildagliptin impurities, answered
What Vildagliptin reference materials are available?
The catalogue currently lists 33 compounds for Vildagliptin, including 1 pharmacopoeial impurity, 3 nitrosamines and 4 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 Vildagliptin 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 Vildagliptin 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.
Do you supply Vildagliptin nitrosamine impurities?
Yes. 3 N-nitroso compounds are listed for Vildagliptin. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.