Description

Sitagliptin Impurity 15 is a specified organic compound used as a reference standard in analytical chemistry. This impurity is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient Sitagliptin, a leading medication for type 2 diabetes. It is primarily required by pharmaceutical manufacturers and analytical laboratories for research, method development, and rigorous quality control processes.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Sitagliptin API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a critical component in batch release testing to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Sitagliptin Impurity 15
CAS No.	2114308-71-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sitagliptin Related Compound 15; Sitagliptin EP Impurity 15; Sitagliptin USP Impurity 15; (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; Januvia Impurity 15; (R)-3-Amino-1-(3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazin-7-yl)-4-(2,4,5-trifluorophenyl)butan-1-one
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Impurity 15 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with relevant pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. The material should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with customer requirements
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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