Description

Sitagliptin Phosphate is the active pharmaceutical ingredient (API) of the widely prescribed antidiabetic drug Januvia®. This high-purity compound is a potent and selective dipeptidyl peptidase-4 (DPP-4) inhibitor, crucial for the treatment of type 2 diabetes mellitus. It is essential for pharmaceutical manufacturers engaged in the formulation of innovative and generic oral antihyperglycemic medications, ensuring therapeutic efficacy and patient safety.

Application

• Pharmaceutical API Manufacturing: Primary active ingredient for the synthesis of DPP-4 inhibitor class antidiabetic drugs.
• Finished Dosage Formulation: Used in the production of oral solid dosage forms, primarily film-coated tablets.
• Generic Drug Development: A key component for companies developing bioequivalent versions of branded sitagliptin medications.
• Research & Development: Serves as a reference standard and starting material in metabolic disorder research and new drug discovery.
• Combination Therapies: Formulated in fixed-dose combination products with other antidiabetic agents like metformin.

Basic Information

Product Name	Sitagliptin Phosphate
CAS No.	654671-78-0
Molecular Formula	C16H15F6N5O • H3PO4 • H2O
Molecular Weight	523.32 g/mol (monohydrate phosphate salt)
Synonyms	Sitagliptin phosphate monohydrate; MK-0431 phosphate; (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; DPP-4 Inhibitor Sitagliptin; STG phosphate; UNII-80JGC7J5S5
EINECS	Contact for details

Quality Control

Our Sitagliptin Phosphate is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP and ICH Q7 guidelines. Every batch is subjected to comprehensive analytical testing including identity, purity, and impurity profile verification. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring full traceability and adherence to your stringent specifications.

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) and must be kept under conditions that minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	2.5% - 4.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5%; Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbial Enumeration	Complies with USP <61> / Ph. Eur. 2.6.12

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