Description

Sitagliptin Impurity 4 CAS NO 1840966-95-1 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Sitagliptin, a leading medication for type 2 diabetes, by enabling precise identification and quantification of related substances. It is an essential tool for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory compliance teams focused on impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Sitagliptin Impurity 4 in Sitagliptin API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Used in routine QA/QC testing to monitor impurity levels and ensure batch-to-batch consistency and specification compliance.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress and long-term storage conditions.
• Research & Process Chemistry: Aids in understanding the formation pathway of this impurity during the synthesis of Sitagliptin, enabling process optimization and control.

Basic Information

Product Name	Sitagliptin Impurity 4
CAS No.	1840966-95-1
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; Januvia Impurity; MK-0431 Impurity
EINECS	Contact for details

Quality Control

Our Sitagliptin Impurity 4 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, assay, purity, and related substances. Our quality commitment aligns with cGMP principles to support your regulatory needs.

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 (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.