Description

Rac-Sitagliptin Phosphate CAS NO 823817-57-8 is a high-purity chemical reference standard and key intermediate in pharmaceutical research and development. This compound is of significant importance for analytical method development, quality control, and impurity profiling in the production of active pharmaceutical ingredients (APIs). It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and academic research institutions focused on metabolic disease therapeutics and process chemistry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of sitagliptin and related substances in drug products and raw materials.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for impurity analysis and assay determination.
• Process Chemistry & Impurity Synthesis: Acts as a starting material or intermediate for the synthesis of process-related impurities and degradation products required for regulatory filings (e.g., ICH guidelines).
• Metabolic Disease Research: Utilized in preclinical and clinical research studies investigating dipeptidyl peptidase-4 (DPP-4) inhibitors and their mechanisms of action.
• Quality Control Laboratories: Employed for system suitability testing, calibration, and as a working standard in the routine QC testing of sitagliptin phosphate monohydrate API and finished dosage forms.

Basic Information

Product Name	Rac-Sitagliptin Phosphate
CAS No.	823817-57-8
Molecular Formula	C16H15F6N5O • H3PO4
Molecular Weight	523.29 g/mol (free base: 407.32)
Synonyms	(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one phosphate; Racemic Sitagliptin Phosphate; (Rac)-Sitagliptin Phosphate; Januvia Impurity; MK-0431 Phosphate Racemate; DPP-4 Inhibitor Intermediate; 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
EINECS	Contact for details

Quality Control

Our Rac-Sitagliptin Phosphate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, chiral analysis, and identification by spectroscopic methods (IR, NMR, MS), to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are provided.

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 dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0% (anhydrous basis)
Chiral Purity (HPLC)	≤2.0% total enantiomeric impurity
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.