Description

Sitagliptin Impurity 24 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Sitagliptin. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is essential for research and development, method validation, and routine batch testing within the pharmaceutical industry, particularly for antidiabetic drug production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Sitagliptin Impurity 24 in Sitagliptin API and finished dosage forms.
• Analytical Method Development & Validation: Crucial for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure impurity levels are within International Council for Harmonisation (ICH) and pharmacopeial limits (USP, EP).
• Stability Studies: Employed to track the formation and growth of this impurity under various stress conditions (heat, light, humidity) during drug shelf-life studies.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the Sitagliptin synthesis pathway to minimize the formation of this specific impurity.

Basic Information

Product Name	Sitagliptin Impurity 24
CAS No.	2349567-54-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
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; Sitagliptin Related Compound 24; Januvia Impurity 24; MK-0431 Impurity 24; DPP-4 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Impurity 24 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results, chromatograms, and traceability information.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term stability, consider storage at 2-8°C. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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