Description

Sitagliptin Monohydrochloride is the hydrochloride salt form of sitagliptin, a potent and selective dipeptidyl peptidase-4 (DPP-4) inhibitor. This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacture of type 2 diabetes therapeutics, ensuring consistent pharmacological activity and formulation stability. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the production of innovative antidiabetic medications and related analytical studies.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of oral antidiabetic drugs for the treatment of type 2 diabetes mellitus.
• Reference Standard: Used in analytical laboratories for quality control, method development, and validation in drug testing.
• Research & Development: Serves as a key intermediate in preclinical and clinical research for new diabetes therapies and combination drugs.
• Generic Drug Manufacturing: Essential for the production of bioequivalent generic versions of DPP-4 inhibitor medications.
• Formulation Studies: Utilized in the development of various dosage forms, including tablets and fixed-dose combinations.

Basic Information

Product Name	Sitagliptin Monohydrochloride
CAS No.	486459-71-6
Molecular Formula	C16H15F6N5O•HCl
Molecular Weight	447.78 g/mol
Synonyms	Sitagliptin HCl; (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 hydrochloride; MK-0431 hydrochloride; Januvia API; DPP-4 Inhibitor Sitagliptin Hydrochloride; 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 hydrochloride
EINECS	Contact for details

Quality Control

Our Sitagliptin Monohydrochloride is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets high-purity pharmacopeial standards. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We support compliance with ICH Q7 guidelines and can supply material referenced to USP/EP monographs upon request.

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 in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Specific Rotation	Contact for details

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