Description

Sitagliptin Phosphate CAS NO 847445-79-8 is the phosphate salt form of sitagliptin, a highly selective and potent dipeptidyl peptidase-4 (DPP-4) inhibitor. This active pharmaceutical ingredient (API) is critical for the formulation of oral anti-diabetic medications used in the management of type 2 diabetes mellitus. It is primarily required by global pharmaceutical manufacturers engaged in the development and production of finished dosage forms, such as tablets.

Application

• Primary Active Pharmaceutical Ingredient (API) for the manufacture of oral anti-diabetic drugs (e.g., Januvia®).
• Formulation of Fixed-Dose Combination Therapies with other anti-diabetic agents like metformin.
• Research and Development of novel DPP-4 inhibitor-based therapeutics in academic and industrial laboratories.
• Pharmaceutical Intermediates for the synthesis of related chemical entities.
• Reference Standard for quality control and analytical method development in pharmaceutical testing.
• Generic Drug Manufacturing for global markets following patent expiry.

Basic Information

Product Name	Sitagliptin Phosphate
CAS No.	847445-79-8
Molecular Formula	C16H15F6N5O • H3PO4 • H2O
Molecular Weight	523.32 g/mol (monohydrate)
Synonyms	Sitagliptin phosphate monohydrate; MK-0431 phosphate; (2R)-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 phosphate salt; STG phosphate; 7-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3-a]pyrazine phosphate monohydrate
EINECS	Contact for details

Quality Control

Our Sitagliptin Phosphate is manufactured under strict quality systems. It undergoes rigorous analytical testing to ensure compliance with ICH guidelines and relevant pharmacopoeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA), detailing purity, identity, and impurity profiles, is provided with each batch to guarantee traceability and regulatory compliance for pharmaceutical use.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
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: ≤ 0.15% Total impurities: ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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