Description

Sitagliptin Carbamoyl -D-Glucuronide is a key metabolite and reference standard of the antidiabetic drug Sitagliptin. This compound is of critical importance for pharmaceutical research and development, particularly in the areas of drug metabolism and pharmacokinetic (DMPK) studies. It is primarily utilized by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in bioanalytical method development and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the quantification of Sitagliptin metabolites in biological matrices during clinical and non-clinical studies.
• Drug Metabolism and Pharmacokinetics (DMPK): Essential for elucidating the metabolic pathways, excretion profiles, and bioavailability of Sitagliptin.
• Bioanalytical Method Development: Used to develop and validate sensitive and specific LC-MS/MS or HPLC methods for therapeutic drug monitoring and pharmacokinetic assays.
• Impurity Profiling: Acts as a characterized impurity standard in the quality control of Sitagliptin active pharmaceutical ingredient (API) and finished dosage forms.
• Regulatory Submissions: Provides essential data to support Investigational New Drug (IND) and New Drug Application (NDA) filings with agencies like the FDA and EMA.

Basic Information

Product Name	Sitagliptin Carbamoyl -D-Glucuronide
CAS No.	940002-59-5
Molecular Formula	C22H30N4O9
Molecular Weight	494.50 g/mol
Synonyms	(2R,3S,4S,5R,6S)-6-(((7-((3R)-3-Amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl)-5,6,7,8-tetrahydro[1,2,4]triazolo[4,3-a]pyrazin-3-yl)oxy)carbonylamino)-3,4,5-trihydroxytetrahydro-2H-pyran-2-carboxylic Acid; MK-0431 Carbamoyl Glucuronide; Sitagliptin Acyl Glucuronide; Januvia Metabolite; Sitagliptin Metabolite M2; (3R)-3-Amino-1-(3-(triazolo[4,3-a]pyrazin-3-yloxy)-8-azabicyclo[3.2.1]oct-8-yl)-4-(2,4,5-trifluorophenyl)butan-1-one Carbamoyl Glucuronide
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Carbamoyl -D-Glucuronide is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and stability testing to ensure compliance with the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for assay, impurities, and identification is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity. Allow the vial to equilibrate to room temperature in a desiccator before opening.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (Mass Spectrometry)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines

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