Description

(S)-Sitagliptin Phosphate CAS NO 823817-58-9 is the active pharmaceutical ingredient (API) form of the widely prescribed dipeptidyl peptidase-4 (DPP-4) inhibitor, sitagliptin. This high-purity compound is critical for ensuring the efficacy and safety of finished pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of antidiabetic medications.

Application

• Active Pharmaceutical Ingredient (API) for the manufacture of sitagliptin-based antidiabetic drugs (e.g., Januvia®, Janumet®).
• Pharmaceutical R&D for developing new formulations, combination therapies, or controlled-release systems for Type 2 Diabetes Mellitus treatment.
• Reference Standard in analytical laboratories for quality control, method development, and validation of sitagliptin drug products.
• Process Chemistry for scale-up studies, optimization of synthetic pathways, and impurity profiling.
• Academic and Clinical Research investigating the mechanisms of DPP-4 inhibition and related metabolic pathways.

Basic Information

Product Name	(S)-Sitagliptin Phosphate
CAS No.	823817-58-9
Molecular Formula	C16H15F6N5O • H3PO4 • H2O
Molecular Weight	523.32 g/mol (monohydrate phosphate salt)
Synonyms	Sitagliptin Phosphate Monohydrate; MK-0431 phosphate; (2R)-4-Oxo-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-2-[4,5-bis(trifluoromethyl)-1H-pyrrol-3-yl]butan-2-aminium phosphate hydrate (1:1:1); Januvia API; DPP-4 Inhibitor Sitagliptin Phosphate
EINECS	Contact for details

Quality Control

Our (S)-Sitagliptin Phosphate is manufactured under strict quality management systems. We provide material that meets or exceeds pharmaceutical-grade standards, with specifications aligned with major pharmacopoeial requirements. Comprehensive testing includes identity, assay, impurity profile (including related substances and residual solvents), and physical characteristics. A Certificate of Analysis (COA) is provided with each batch to ensure full traceability and compliance.

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 conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	2.0% - 4.0%
Related Substances (HPLC)	Individual unspecified impurity: NMT 0.10% Total impurities: NMT 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Specific Rotation	Contact for details

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