HomeProducts

Sitagliptin phosphate

CAS Number
654671-78-0
EC Number
N/A
Chemical Formula
C16H15F6N5O.H3O4P
Molecular Weight
523.32 g/mol

Description

Sitagliptin phosphate (CAS 654671-78-0 ) is the phosphate salt form of sitagliptin, a DPP-4 inhibitor active pharmaceutical ingredient developed for the management of type 2 diabetes. Sitagliptin phosphate monohydrate is the primary commercially distributed hydrate form, while the anhydrous grade serves distinct formulation requirements for pharmaceutical manufacturers. Both forms are sourced by pharmaceutical manufacturers and API importers as the basis for finished oral dosage production. The compound is the active ingredient in oral antidiabetic tablet formulations. It functions as the DPP-4 enzyme inhibitor delivering the therapeutic effect. Contract manufacturers and generic drug producers source it to develop bioequivalent products following patent expiry. It is also used in fixed-dose combination tablets paired with metformin, requiring compatibility evaluation. Analytical and QA laboratories procure reference-grade material for method validation. Sitagliptin phosphate is supplied as a white to off-white crystalline powder in both monohydrate and anhydrous forms. Standard grades include API-grade material manufactured under ICH Q7 GMP guidelines. Specifications are aligned to pharmacopoeial standards such as USP , Ph.Eur. , BP , and EP . Packaging is typically offered in kilogram-scale quantities suited to clinical batch manufacturing. These quantities are also ideal for commercial production runs. The material ensures high purity and stability for long-term storage and distribution within the global pharmaceutical supply chain. Contact us for supply of Sitagliptin phosphate Request Quote

Other Names (Synonyms)

sitagliptin phosphate anhydrous | Sitagliptin phosphate monohydrate | Sitagliptin phosphate hydrate | Glactiv | sitagliptin monophosphate monohydrate | TS63EW8X6F

Key Technical Features

  • High Purity Grade standard
  • Consistent Batch Quality
  • Full Regulatory & REACH Support
  • Global Logistics Network enabled

Physical Properties

Melting Point213-216 °C
AppearanceWhite Solid
ColorWhite to Off-White
FormSolid

Safety & Handling

Warning
GHS07· IrritantGHS08· Health Hazard

Hazard Statements

H315Causes skin irritation
H319Causes serious eye irritation
H373May causes damage to organs through prolonged or repeated exposure

Precautionary Statements

P260Do not breathe dust/fume/gas/mist/vapours/spray.
P264Wash … thoroughly after handling.
P280Wear protective gloves/protective clothing/eye protection/face protection.
P319Get medical advice/attention if you feel unwell.
P321Specific treatment (see … on this label).
P501Dispose of contents/container in accordance with local regulations.
P265Wash … thoroughly after handling.
P352IF ON SKIN: Wash with plenty of water.
P317Get emergency medical help.
P317If eye irritation persists: Get medical advice/attention. Get emergency medical help.
P364Take off contaminated clothing and wash it before reuse.
P338IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.