Description

Rac-Sitagliptin CAS NO 823817-56-7 is the racemic form of Sitagliptin, a key pharmaceutical intermediate and reference standard. This compound is of significant importance for research and development in the pharmaceutical industry, particularly for analytical method development and impurity profiling. It is primarily needed by pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in the development and quality control of antidiabetic medications.

Application

• Pharmaceutical Reference Standard: Used as a critical standard for the identification and quantification of Sitagliptin and its related substances in drug substances and finished products.
• Analytical Method Development: Essential for developing and validating chromatographic (HPLC, UPLC) and spectroscopic methods in quality control laboratories.
• Impurity Profiling and Characterization: Serves as a starting material or comparative standard for the synthesis and study of stereoisomeric impurities in active pharmaceutical ingredients (APIs).
• Process Chemistry Research: Utilized in research to study chiral separation techniques, crystallization processes, and the synthesis pathways of dipeptidyl peptidase-4 (DPP-4) inhibitors.
• Academic and Clinical Research: Employed in pharmacological studies to investigate the structure-activity relationships and metabolic pathways of DPP-4 inhibitors.

Basic Information

Product Name	Rac-Sitagliptin
CAS No.	823817-56-7
Molecular Formula	C16H15F6N5O
Molecular Weight	407.32 g/mol
Synonyms	(±)-Sitagliptin; Racemic Sitagliptin; 7-[(3R,4S)-3-Amino-1-(2,4,5-trifluorophenyl)-4-(2,2,2-trifluoroethyl)pyrrolidin-2-yl]-5,6,7,8-tetrahydro[1,2,4]triazolo[4,3-a]pyrazine; 1,2,4-Triazolo[4,3-a]pyrazine, 7-[(3R,4S)-3-amino-1-(2,4,5-trifluorophenyl)-4-(2,2,2-trifluoroethyl)-2-pyrrolidinyl]-5,6,7,8-tetrahydro-, (+)-; UNII-9V2K61S6SY (component); Januvia Impurity; DPP-4 Inhibitor Intermediate
EINECS	Contact for details

Quality Control

Our Rac-Sitagliptin is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chiral purity determination, to ensure it meets high-purity standards suitable for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data (HPLC) are provided to guarantee traceability and batch-to-batch consistency.

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 dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≤ 2.0% of undesired enantiomer
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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