Sitagliptin Phosphate is a premier Active Pharmaceutical Ingredient (API) belonging to the dipeptidyl peptidase-4 (DPP-4) inhibitor class, synthesized and manufactured by Parand Darou Co. This essential API serves as the therapeutic backbone for oral antidiabetic formulations designed to regulate glycemic levels and optimize metabolic control in patients with Type 2 Diabetes Mellitus.
Mechanism of Action & Clinical Advantages
Sitagliptin operates through the potent, selective, and competitive inhibition of the DPP-4 enzyme, preventing the enzymatic degradation of active incretin hormones, notably glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). This elevation of active incretins stimulates glucose-dependent insulin biosynthesis and exocytosis while simultaneously suppressing postprandial glucagon secretion from pancreatic alpha cells. Prominent clinical advantages include a markedly low risk of hypoglycemia and neutral effects on body weight.
Standards, Quality & Storage
Manufactured in rigorous compliance with the highest compendial standards of both the United States Pharmacopeia (USP) and the British Pharmacopoeia (BP), Sitagliptin Phosphate at Parand Darou exhibits an ultra-high chemical purity profile (minimum 99.5%). The product is packaged in well-closed containers, stored at controlled room temperature, and guarantees complete chemical and physical stability for a minimum shelf life of 24 months.
General Information
| Product Name | Sitagliptin Phosphate | |
| Chemical Name | (3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate | |
| Manufacturer | Parand Darou Co. | |
| CAS No. | 654671-77-9 | |
| Category | Antidiabetic (DPP-4 Inhibitor) | |
| Pharmacopoeia | USP, BP |
Specification
| Molecular formula | C16H15F6N5O · H3PO4 · H2O | Purity | Min. 99.5% | |||
| Molecular weight | 523.32 | Assay | 98.0% to 102.0% (anhydrous basis) | |||
| Appearance | White or off-white, crystalline powder | Water | 3.1% – 4.0% | |||
| Solubility | Freely sol. in water; slightly sol. in methanol; insol. in isopropanol | Storage | Well-closed container at R.T. | |||
| Stability | Stable 2 yrs at R.T. |
