Sitagliptin phosphate

CAS Number
654671-78-0

What is Sitagliptin phosphate?

Sitagliptin phosphate (CAS 654671-78-0) is the phosphate salt form of sitagliptin, a DPP-4 inhibitor active pharmaceutical ingredient for managing type 2 diabetes.

Where is Sitagliptin phosphate used?

  • Oral antidiabetic tablet formulations: active ingredient
  • DPP-4 enzyme inhibitor delivering the therapeutic effect
  • Fixed-dose combination tablets paired with metformin, requiring compatibility evaluation
  • Reference-grade material for method validation in analytical and QA laboratories
  • Pharmaceutical manufacturers and API importers source both hydrate forms as the basis for finished oral dosage production.

Good to know: Sitagliptin phosphate monohydrate is the primary commercially distributed hydrate form; the anhydrous grade serves distinct formulation requirements. Specifications are aligned to pharmacopoeial standards such as USP, Ph. Eur., BP, and EP.

Commercial specifications

  • API-grade material manufactured under ICH Q7 GMP guidelines
  • Packaging typically in kilogram-scale quantities suited to clinical batch manufacturing and commercial production runs

Other Names (Synonyms)

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

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What are the physical properties of Sitagliptin phosphate?

Melting Point 213-216 °C
Appearance White Solid
Color White to Off-White
Form Solid

How is Sitagliptin phosphate classified and handled safely? Learn More

Warning
GHS07· Irritant GHS08· Health Hazard

Hazard Statements

H315 Causes skin irritation
H319 Causes serious eye irritation
H373 May causes damage to organs through prolonged or repeated exposure

Precautionary Statements

P260 Do not breathe dust/fume/gas/mist/vapours/spray.
P264 Wash … thoroughly after handling.
P280 Wear protective gloves/protective clothing/eye protection/face protection.
P319 Get medical advice/attention if you feel unwell.
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