Description

Sitagliptin Ep Impurity C CAS NO 1345822-86-7 is a high-purity reference standard used for analytical and quality control purposes in the pharmaceutical industry. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Sitagliptin, a leading medication for type 2 diabetes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Sitagliptin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Sitagliptin products comply with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing definitive impurity characterization data for agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions to establish product shelf-life.
• Research & Development: Used in R&D to study impurity formation pathways and optimize synthesis processes to minimize related substances.

Basic Information

Product Name	Sitagliptin Ep Impurity C
CAS No.	1345822-86-7
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; (R)-3-Amino-1-(5,6-dihydro-3-(trifluoromethyl)-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one; Sitagliptin Impurity C; Sitagliptin Related Compound C; Januvia Impurity C; MK-0431 Impurity C; Sitagliptin EP Impurity C
EINECS	Contact for details

Quality Control

Our Sitagliptin Ep Impurity C is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided, detailing the results against stringent in-house specifications aligned with pharmacopeial standards. We support regulatory needs with full traceability and stability data.

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 under inert conditions or in a desiccator to prevent degradation. Handle in a well-ventilated laboratory environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (on dried basis)	97.0% - 103.0%

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