Description

Sitagliptin Impurity 26 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and manufacturing of the antidiabetic drug Sitagliptin. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, impurity profiling, and regulatory compliance. Ensuring the integrity of this impurity standard is fundamental to maintaining drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sitagliptin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required in drug master files (DMFs).
• Stability Studies: Employed to monitor impurity levels in Sitagliptin formulations under various stress conditions to establish shelf-life and storage recommendations.
• Process Chemistry Research: Used by R&D scientists to study the formation pathways of this impurity during Sitagliptin synthesis, aiding in process optimization and control.
• Quality Assurance/Quality Control (QA/QC): Serves as a primary standard for routine batch release testing in pharmaceutical QC laboratories to ensure product purity meets pharmacopeial specifications.

Basic Information

Product Name	Sitagliptin Impurity 26
CAS No.	1402569-71-4
Molecular Formula	C16H15F6N5O
Molecular Weight	407.31 g/mol
Synonyms	1-[(4-Oxo-4-{3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl}-1-(2,4,5-trifluorophenyl)butan-2-yl)amino]acetamide; (2R)-4-Oxo-1-(2,4,5-trifluorophenyl)-4-[3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4]triazolo[4,3-a]pyrazin-7-yl]butan-2-amine Acetamide Derivative; Sitagliptin Related Compound 26; Januvia Impurity 26; MK-0431 Impurity 26
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Impurity 26 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques including HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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