Sitagliptin phosphate

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.