Description

Sitagliptin Defluoro Impurity 3 is a specified impurity and a key chemical reference standard used in the pharmaceutical development and quality control of Sitagliptin, an important antidiabetic drug. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, validation, and batch release of Sitagliptin and its formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Sitagliptin API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure compliance with strict pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation and level of this specific degradation product under various storage conditions.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Sitagliptin to minimize the formation of this impurity.

Basic Information

Product Name	Sitagliptin Defluoro Impurity 3
CAS No.	851307-12-5
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; Desfluoro Sitagliptin Impurity 3; Sitagliptin Des-Fluoro Impurity C; Sitagliptin EP Impurity C; Januvia Impurity C; MK-0431 Impurity C; 1-[[(3R)-3-Amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]amino]acetyl-2-(2,5-difluorophenyl)-4,5-difluorobenzene (common name variant); BMS-477118 Impurity (related compound)
EINECS	Contact for details

Quality Control

Our Sitagliptin Defluoro Impurity 3 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and accurate characterization, suitable for use as a reference standard. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity, and impurity profile by validated methods (e.g., HPLC, NMR). We support compliance with ICH Q3A/B, USP, and European Pharmacopoeia standards for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

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% w/w
Residue on Ignition	≤ 0.1%

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