Description

Teneligliptin Hydrobromide Hydrate is the hydrobromide salt hydrate form of Teneligliptin, a potent and selective dipeptidyl peptidase-4 (DPP-4) inhibitor. This active pharmaceutical ingredient (API) is critical for the formulation of oral anti-diabetic medications, offering a stable and bioavailable form for consistent therapeutic effect. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for type 2 diabetes mellitus.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of anti-diabetic tablets and formulations.
• Drug Substance Synthesis: Serves as a key intermediate or final salt form in the synthesis of Teneligliptin-based medications.
• Research & Development: Utilized in preclinical and clinical studies for investigating DPP-4 inhibition and diabetes management.
• Reference Standard: Acts as a high-purity chemical reference standard for analytical method development and quality control testing.
• Formulation Development: Used in the development of novel drug delivery systems, including fixed-dose combinations.
• Generic Drug Manufacturing: Essential for companies producing generic versions of Teneligliptin medications post-patent expiry.

Basic Information

Product Name	Teneligliptin Hydrobromide Hydrate
CAS No.	1572583-29-9
Molecular Formula	C22H30N6O5S • HBr • xH2O
Molecular Weight	Contact for details
Synonyms	Teneligliptin HBr Hydrate; 5-[(2S,4S)-4-[4-(3-Methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl]pyrrolidin-2-yl]methoxy-2,4-dihydro-3H-1,2,4-triazol-3-one hydrobromide hydrate; TNP-2092 Hydrobromide Hydrate; (2S,4S)-1-[(2S)-2-Amino-3,3-dimethylbutanoyl]-4-hydroxy-N-[[4-(4-methyl-1,3-thiazol-5-yl)phenyl]methyl]pyrrolidine-2-carboxamide hydrobromide hydrate (Related to core structure); DPP-4 Inhibitor Teneligliptin Salt
EINECS	Contact for details

Quality Control

Our Teneligliptin Hydrobromide Hydrate is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. A comprehensive Certificate of Analysis (COA) is provided, detailing parameters such as assay, impurities, and identification. We support compliance with ICH Q7 guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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, which may affect stability and handling properties.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	Contact for details
Related Substances (HPLC)	Individual impurity: ≤0.5% Total impurities: ≤2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	<20 ppm

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