Description

Gosogliptin Hydrochloride is a high-purity active pharmaceutical ingredient (API) belonging to the dipeptidyl peptidase-4 (DPP-4) inhibitor class. This compound is of significant commercial and therapeutic interest for its role in the research and development of novel anti-diabetic medications. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in metabolic disease research and drug formulation. Our supply is characterized by stringent quality control, ensuring reliability for critical development and manufacturing processes.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of anti-diabetic drugs targeting type 2 diabetes mellitus.
• Reference Standard: Used as a certified reference material (CRM) for analytical method development, validation, and quality control testing in laboratories.
• Preclinical & Clinical Research: Essential for pharmacological studies, pharmacokinetic/pharmacodynamic (PK/PD) modeling, and toxicity assessments during drug discovery.
• Process Chemistry & Development: Serves as a key intermediate or final compound for optimizing synthetic routes and scale-up processes.
• Regulatory Submissions: Supplied with full supporting documentation (COA, MSDS) for use in Investigational New Drug (IND) and New Drug Application (NDA) filings.
• Academic Research: Utilized in university and institutional studies exploring the mechanisms of DPP-4 inhibition and glucose metabolism.

Basic Information

Product Name	Gosogliptin Hydrochloride
CAS No.	869490-47-1
Molecular Formula	C19H25FN6O2 • HCl
Molecular Weight	424.90 g/mol (Hydrochloride salt)
Synonyms	Gosogliptin HCl; (3R)-3-Amino-4-(2,4,5-trifluorophenyl)-N-({3-[(1R)-2,2,2-trifluoro-1-hydroxyethyl]-1H-pyrazol-1-yl}acetyl)butanamide hydrochloride; PF-00734200 hydrochloride; DPP-4 Inhibitor (PF-00734200); 1-({[(3R)-3-Amino-1-oxo-4-(2,4,5-trifluorophenyl)butan-2-yl]amino}acetyl)-3-[(1R)-2,2,2-trifluoro-1-hydroxyethyl]-1H-pyrazole hydrochloride
EINECS	Contact for details

Quality Control

Our Gosogliptin Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical development. We provide full traceability and support with detailed Certificates of Analysis (COA), which include data from HPLC, NMR, and mass spectrometry. Our quality commitment aligns with ICH guidelines and current Good Manufacturing Practice (cGMP) principles for APIs.

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 (moisture-sensitive) nature, the container must be kept in a dry environment and opened under conditions of low humidity to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Optical Rotation	Specific range provided on COA

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