Description

Sitagliptin Deamino Impurity 1 is a high-purity reference standard and pharmaceutical intermediate critical for quality control in the manufacturing of the antidiabetic drug Sitagliptin. This compound is essential for analytical method development, validation, and ensuring the purity and safety of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development and quality assurance of DPP-4 inhibitor therapeutics.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of related substances in Sitagliptin API and finished dosage forms.
• Critical component in analytical method development and validation (e.g., HPLC, UPLC, LC-MS) for impurity profiling.
• Essential raw material for pharmaceutical research and development to study degradation pathways and stability profiles.
• Used in quality control (QC) and quality assurance (QA) laboratories to comply with ICH guidelines and regulatory filings (e.g., FDA, EMA).
• Key intermediate in process chemistry research for optimizing synthetic routes to minimize impurity formation.
• Supplies for academic and institutional research focusing on diabetes treatment and drug metabolism.

Basic Information

Product Name	Sitagliptin Deamino Impurity 1
CAS No.	1253056-18-6
Molecular Formula	C16H15F6N5O
Molecular Weight	407.31 g/mol
Synonyms	Deamino Sitagliptin Impurity; (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; Sitagliptin EP Impurity G; Sitagliptin USP Related Compound G; 1-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Deamino Impurity 1 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, impurities, and residual solvents.

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 must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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