Description

Sitagliptin CAS NO 486460-32-6 is a potent, highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor used as an active pharmaceutical ingredient (API). It is a critical component in the formulation of oral anti-diabetic medications for the management of type 2 diabetes mellitus. This high-purity compound is essential for pharmaceutical manufacturers and research institutions focused on developing and producing effective metabolic disorder therapeutics.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of DPP-4 inhibitor class anti-diabetic drugs.
• Formulation Development: Used in R&D for creating fixed-dose combination tablets and other oral solid dosage forms.
• Reference Standard: Serves as a high-purity chemical reference standard for quality control and analytical method development in laboratories.
• Clinical Research: Employed in preclinical and clinical studies investigating new diabetes treatments and combination therapies.
• Generic Drug Manufacturing: Key raw material for the production of generic versions of branded sitagliptin medications.

Basic Information

Product Name	Sitagliptin
CAS No.	486460-32-6
Molecular Formula	C16H15F6N5O
Molecular Weight	407.31 g/mol
Synonyms	Sitagliptin Phosphate; MK-0431; (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; Januvia (Brand Name API); Tesavel (Brand Name API); Xelevia (Brand Name API); DPP-4 Inhibitor Sitagliptin; 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
EINECS	Contact for details

Quality Control

Our Sitagliptin is manufactured under strict quality management systems. It undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications, with typical purity exceeding 99.0%. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles. We adhere to cGMP guidelines where applicable to ensure supply reliability and batch-to-batch consistency for our global partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 99.0%
Related Substances (HPLC)	Total impurities ≤ 0.5% Any single unknown impurity ≤ 0.10%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 10 ppm
Loss on Drying	≤ 0.5%
Specific Rotation	Contact for details

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