Description

Sitagliptin Ep Impurity C is a specified impurity and degradation product of the active pharmaceutical ingredient Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. This compound is critical for pharmaceutical quality control and regulatory compliance, serving as a reference standard for analytical method development and validation. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in the research, development, and quality assurance of Sitagliptin-based antidiabetic medications.

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: Crucial for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Sitagliptin products meet pharmacopoeial specifications (e.g., USP, EP, ICH guidelines) for impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Research & Development: Facilitates studies on the degradation pathways and chemical stability of Sitagliptin during formulation development.

Basic Information

Item	Detail
Product Name	Sitagliptin Ep Impurity C
CAS No.	945261-48-3
Molecular Formula	C16H15F6N5O
Molecular Weight	407.32 g/mol
Synonyms	(2R)-1-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6-dihydro-1H,3H-pyrrolo[1,2-c]imidazol-2-one; Sitagliptin EP Impurity C; Sitagliptin Related Compound C; Januvia Impurity C; MK-0431 Impurity C
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopoeial standards and ICH guidelines. 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 in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and the container kept sealed when not in use to prevent moisture absorption.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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