Description

Sitagliptin Defuoro Impurity 5 is a specified impurity and a key chemical reference standard used in the pharmaceutical development and quality control of Sitagliptin, an important antidiabetic medication. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark for analytical method validation and impurity profiling. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs professionals involved in the synthesis, testing, and regulatory submission of Sitagliptin and its related drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Sitagliptin API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing, optimizing, and validating chromatographic methods for impurity detection.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Employed to track the formation of this specific degradation product during forced degradation and long-term stability testing of Sitagliptin.
• Process Chemistry Research: Used by R&D scientists to study and optimize the synthetic pathway of Sitagliptin to minimize the formation of this impurity.

Basic Information

Product Name	Sitagliptin Defuoro Impurity 5
CAS No.	486460-31-5
Molecular Formula	C₁₆H₁₅F₆N₅O
Molecular Weight	407.32 g/mol
Synonyms	1-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butyl]-3-(trifluoromethyl)-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3-a]pyrazine; (R)-1-(3-Amino-4-(2,4,5-trifluorophenyl)butyl)-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine; Sitagliptin Desfluoro Impurity 5; Januvia Desfluoro Impurity 5; Sitagliptin Related Compound 5; MK-0431 Desfluoro Impurity 5
EINECS	Contact for details

Quality Control

Our Sitagliptin Defuoro Impurity 5 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 and released with a comprehensive Certificate of Analysis (COA) that includes data for identity, purity, and impurity profile. We adhere to relevant industry guidelines, including ICH standards, to support our clients' regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual 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.