Description

Sitagliptin D4 Hydrochloride is a deuterium-labeled analog of the active pharmaceutical ingredient Sitagliptin, a potent and selective dipeptidyl peptidase-4 (DPP-4) inhibitor. This stable isotope-labeled compound is an essential internal standard for the precise quantification and pharmacokinetic studies of Sitagliptin in biological matrices using mass spectrometry. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical chemistry departments for method development, validation, and bioanalytical research.

Application

• Bioanalytical Internal Standard: Serves as a critical reference standard for the accurate LC-MS/MS quantification of Sitagliptin in plasma, serum, and other biological samples.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion in preclinical and clinical research.
• Drug Metabolism Studies: Used in metabolite identification and profiling to understand the biotransformation pathways of Sitagliptin.
• Method Development & Validation: Essential for developing and validating robust, sensitive, and specific analytical methods in compliance with GLP and FDA/EMA guidelines.
• Quality Control & Impurity Profiling: Can be employed as a reference in the analysis of drug substances and products for related substances.
• Stable Isotope Dilution Assays: Provides high accuracy and precision in quantitative analyses by minimizing matrix effects and ion suppression.

Basic Information

Product Name	Sitagliptin D4 Hydrochloride
CAS No.	1620233-72-8
Molecular Formula	C16H11D4F6N5O • HCl
Molecular Weight	445.81 g/mol (for free base C16H11D4F6N5O)
Synonyms	(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one D4 Hydrochloride; Januvia D4 Hydrochloride; MK-0431 D4 Hydrochloride; (R)-3-Amino-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one D4 Hydrochloride; Sitagliptin-d4 HCl; Deuterated Sitagliptin Hydrochloride
EINECS	Contact for details

Quality Control

Our Sitagliptin D4 Hydrochloride is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical identity, which are critical for its use as an analytical standard. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and MS. A comprehensive Certificate of Analysis (COA) is provided, detailing isotopic enrichment (typically >98% D), chemical purity (by HPLC), and confirming structural identity. Our quality system supports research conducted under GLP and other regulatory frameworks.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, or as indicated on the label. This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. Keep the container tightly sealed in a cool, dry, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D-content)	≥98 atom % D
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

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