Sitagliptin phosphate

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.

Structure

2D structure of Sitagliptin phosphate

Sitagliptin phosphate: 2D structure drawn from the PubChem record (CID 4369359).

Compound data

CAS number

486460-32-6

Formula

C16H15F6N5O

Molecular weight

407.32 g/mol

Type

DPP-4 inhibitor

Structure and names

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

How Vanguard tests Sitagliptin phosphate

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.

What's reported

  • Purity, as percent of total peak area
  • Quantity, against the label claim
  • Identity, reported as match or no match against the reference standard
  • With monograph testing (quoted): the monograph’s tests against its limits

Tests and prices

$250

Chromatographic purity and mg per unit by the method matched to the compound, identity against a reference standard. 1 unit.

$200

Chromatographic purity on bulk powder. 50 mg.

Add-on tests

Add-on testPrice
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.

Sample amount and turnaround

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.

Salts, forms and compendial references

  • Sitagliptin (CAS 486460-32-6)
  • Sitagliptin Phosphate
  • Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Sitagliptin phosphate testing

Is the $250 test the same as USP monograph testing?

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.

Why does the monograph test enantiomeric purity?

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.

Is sitagliptin phosphate a monohydrate?

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.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/4369359

Identity facts from the USP monograph header for this compound.

Order

Start an order online, or send the compound name and the tests you need for a quote.