Description

Sitagliptin Phosphate Monohydrate is the phosphate salt monohydrate form of sitagliptin, a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor. This active pharmaceutical ingredient (API) is critical for the formulation of oral anti-diabetic medications, offering a targeted mechanism for managing type 2 diabetes mellitus. It is primarily required by global pharmaceutical manufacturers engaged in the development and production of solid dosage forms, such as tablets. CAS NO 654671-77-9.

Application

• Pharmaceutical API: The primary and most significant application is as the active ingredient in the manufacture of anti-diabetic drugs, specifically DPP-4 inhibitor class medications.
• Tablet Formulation: Used in the development and commercial production of oral solid dosage forms, often in combination with other agents like metformin.
• Drug Product R&D: Serves as a key reference standard and raw material in pharmaceutical research laboratories for developing new formulations and delivery systems.
• Generic Drug Manufacturing: Essential for companies producing generic versions of branded sitagliptin-based therapies after patent expiry.
• Clinical Trial Material: Supplied as a GMP-grade material for the production of batches used in clinical studies and bioequivalence testing.
• Analytical Reference Standard: High-purity grades are utilized in quality control laboratories for method development, validation, and routine testing.

Basic Information

Product Name	Sitagliptin Phosphate Monohydrate
CAS No.	654671-77-9
Molecular Formula	C16H15F6N5O·H3PO4·H2O
Molecular Weight	523.32 g/mol
Synonyms	Sitagliptin phosphate hydrate; MK-0431 phosphate monohydrate; (R)-4-Oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine phosphate monohydrate; Januvia API; Tesavel API; Xelevia API; DPP-4 Inhibitor Sitagliptin Phosphate
EINECS	Contact for details

Quality Control

Our Sitagliptin Phosphate Monohydrate is manufactured under strict quality management systems. It is typically supplied to meet pharmaceutical-grade specifications suitable for API use, with testing aligned with major pharmacopoeial standards. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles to ensure compliance with your regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	3.0% - 4.5%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Microbial Enumeration	Complies with Ph. Eur. 2.6.12 / USP <61>

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.