Description

Sitagliptin Impurity 2 is a specified impurity associated with the active pharmaceutical ingredient Sitagliptin, a widely used dipeptidyl peptidase-4 (DPP-4) inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Sitagliptin-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sitagliptin API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control & Assurance: Employed in routine QC testing of Sitagliptin batches to ensure they meet stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of drug substances and products.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the impurity profile.
• Research & Development: Supports process chemistry research to understand the formation pathway and implement controls to minimize this impurity during API synthesis.

Basic Information

Product Name	Sitagliptin Impurity 2
CAS No.	945261-45-0
Molecular Formula	C16H15F6N5O
Molecular Weight	407.31 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; 7-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4]triazolo[4,3-a]pyrazine; Sitagliptin Related Compound; Januvia Impurity; MK-0431 Impurity
EINECS	Contact for details

Quality Control

Our Sitagliptin Impurity 2 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including identification (IR, NMR), purity assay (HPLC), and control of related substances. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards for pharmaceutical impurities.

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 under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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