Sitagliptin Phosphate Monohydrate

Sitagliptin Phosphate is the phosphate salt form of sitagliptin, an orally available, competitive, beta-amino acid-derived inhibitor of dipeptidyl peptidase 4 (DDP-4) with hypoglycemic activity. Sitagliptin may cause an increased risk in the development of pancreatitis.

General Properties and Specifications of Sitagliptin Phosphate Monohydrate:
Appearance: White or almost white powder.
Assay: 98% minimum.
Solubility: Soluble in DMSO and in water.
Storage: Refrigerate. OK to freeze. Preserve in a well colsed container.

DEFINITION
Sitagliptin Phosphate contains NLT 98.0% and NMT 102.0% of sitagliptin phosphate (C16H15F6N5O-H3PO4), calculated on the anhydrous and solvent-free basis.

IDENTIFICATION
A. Infrared Absorption
B. Meets the requirements of the test for Enantiomeric Purity.
C. Identification Tests—General, Phosphate: A solution containing about 40 mg/mL in water meets the requirements of the silver nitrate precipitation tests for orthophosphates.
Organic Impurities: to pass the test by Chromatography.
Water Determination: 3.3%–3.7%

Sitagliptin Phosphate Monohydrate BP Ph Eur Grade Specifications:
C16H18F6N5O5P,H2O --- 523.3 CASC654671-77-9
Action and use: Dipeptidylpeptidase-4 inhibitor; treatment of diabetes mellitus.

TESTS
Enantiomeric purity: To pass the test by Liquid chromatography.
Related substances: To pass the test by Liquid chromatography.
Water: 3.3 per cent to 3.7 per cent, determined on 0.300 g.
Sulfated ash: Maximum 0.2 per cent, determined on 1.0 g in a platinum crucible.

For Original Monographs of IP Indian Pharmacopoeia EP Ph Eur European Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.