Description

Sitagliptin Impurity C CAS NO 1675201-13-4 is a specified, high-purity chemical reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Sitagliptin. This impurity is critical for ensuring the quality, safety, and efficacy of Sitagliptin-based drug products by enabling accurate identification and quantification during pharmaceutical development and manufacturing. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, particularly those involved in method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Sitagliptin API and finished drug products.
• Method Development and Validation: Critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Release Testing: Used in routine QC testing to monitor and control the level of this specific impurity in commercial batches of Sitagliptin.
• Stability Studies: Employed to identify and track the formation of Sitagliptin Impurity C in stability samples under various ICH-prescribed conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity thresholds and justify specifications.
• Research and Development: Supports impurity identification, synthesis pathway optimization, and degradation studies during API process development.

Basic Information

Product Name	Sitagliptin Impurity C
CAS No.	1675201-13-4
Molecular Formula	C16H15F6N5O
Molecular Weight	407.31 g/mol
Synonyms	(2R)-4-Oxo-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-2-(2,4,5-trifluorophenyl)butan-2-amine; (R)-4-Oxo-1-(3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazin-7-yl)-2-(2,4,5-trifluorophenyl)butan-2-amine; Sitagliptin EP Impurity C; Sitagliptin USP Impurity C; Januvia Impurity C; MK-0431 Impurity C
EINECS	Contact for details

Quality Control

Our Sitagliptin Impurity C is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination, spectroscopic identification (IR, NMR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every 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 or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5%
Total Impurities	≤ 2.0%
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.