Description

Sitagliptin Defluoro Impurity 4 is a high-purity reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Sitagliptin. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical formulations by serving as a key marker for process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality control of antidiabetic medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Sitagliptin Defluoro Impurity 4 in Sitagliptin API and finished drug products.
• Method Development and Validation: Essential for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control impurity levels to comply with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Sitagliptin.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization.
• Process Chemistry Research: Aids chemists in optimizing synthetic routes to minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Sitagliptin Defluoro Impurity 4
CAS No.	1271773-97-7
Molecular Formula	C16H15F6N5O
Molecular Weight	407.31 g/mol
Synonyms	7-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine; Defluoro Sitagliptin Impurity; Januvia Defluoro Impurity; MK-0431 Defluoro Impurity; Sitagliptin Related Compound 4; (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
EINECS	Contact for details

Quality Control

Our Sitagliptin Defluoro Impurity 4 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to support your regulatory and quality assurance requirements.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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