Description

Sitagliptin Impurity 26 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antidiabetic drug Sitagliptin. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analytical testing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and manufacturers of active pharmaceutical ingredients (APIs) who require reliable reference standards for method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Sitagliptin Impurity 26 in Sitagliptin API and finished dosage forms.
• Analytical Method Development and Validation: Crucial for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in compliance with ICH guidelines.
• Quality Control and Batch Release: Used in routine QA/QC testing to monitor impurity levels and ensure every batch of Sitagliptin API meets stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Supports the preparation of regulatory filings (e.g., FDA, EMA) by providing definitive impurity characterization data required for drug approval.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Sitagliptin synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Sitagliptin Impurity 26
CAS No.	1256815-03-8
Molecular Formula	C16H15F6N5O
Molecular Weight	407.32 g/mol
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; (R)-3-Amino-1-(5,6-dihydro-3-(trifluoromethyl)-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one; 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 controlled under a strict quality management system. The product undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and strength conform to the highest standards. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results for assay, related substances, residual solvents, and other critical parameters relevant to pharmaceutical reference standards.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
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%

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