Sitagliptin phosphate: dPP-4 inhibitor.
Sitagliptin phosphate testing at Vanguard Laboratory: identity, purity and quantity $250 per sample, with results in 3 to 5 business days.
Sitagliptin phosphate: 2D structure drawn from the PubChem record (CID 4369359).
486460-32-6
C16H15F6N5O
407.32 g/mol
DPP-4 inhibitor
Identity: Sitagliptin (free base)
IUPAC name: (3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one
Method for the $250 identity, purity and quantity test: HPLC-UV purity and assay, LC-MS identity, against a reference standard, with results in 3 to 5 business days.
The USP Sitagliptin Phosphate monograph covers identity by infrared spectroscopy, a phosphate test and chiral HPLC, assay by HPLC, organic impurities and enantiomeric purity by HPLC, and water content. Full testing to the USP Sitagliptin Phosphate monograph is available and quoted.
Chromatographic purity and mg per unit by the method matched to the compound, identity against a reference standard. 1 unit.
| Add-on test | Price |
|---|---|
| Identity and impurities | |
| FTIR identity | $90 |
| CHNS elemental analysis (carbon, hydrogen, nitrogen, sulfur) | $125 |
| Chiral purity (where a chiral method exists; new methods quoted) | $250 |
| Water, solvents and salt form | |
| Water content by Karl Fischer | $60 |
| Residual solvents | $150 |
| Counterions: chloride, acetate and TFA | $70 |
| Assay | |
| Assay, % w/w (with raw powder purity; $250 together) | +$50 |
| Metals and conformity | |
| Heavy metals: arsenic, cadmium, chromium, mercury and lead | $150 |
| Conformity: purity and quantity on more units from the same lot | $100 per extra unit |
| Microbiology (injectables) | |
| Endotoxin | $210 |
| Sterility or bioburden | $150 |
| Container closure integrity (CCI) | $50 |
| Screening | |
| Fentanyl screen | $50 |
10% off for 10 or more samples.
Need something else? Other tests are available on request.
Purity and quantity is $250 per sample (1 unit) and raw powder purity is $200 for 50 mg, with results in 3 to 5 business days. Send the material sealed and labeled, with the label claim and the form it contains.
No. The $250 test covers identity, purity and quantity by HPLC with UV detection for purity and assay, and LC-MS for identity. Full testing to the USP Sitagliptin Phosphate monograph is available and quoted.
Sitagliptin has one chiral center and only the R form is the intended compound. The other enantiomer has the same mass, so a chiral HPLC method is needed to measure it.
The common raw material is the phosphate monohydrate. Salt and water both add weight, so tell us which form is on the label and quantity is reported on that basis.
https://pubchem.ncbi.nlm.nih.gov/compound/4369359
Identity facts from the USP monograph header for this compound.
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