Description

Sitagliptin Impurity CAS NO 1152439-74-1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Sitagliptin, a key medication for type 2 diabetes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in Sitagliptin API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accurate impurity detection.
• Quality Control and Assurance (QC/QA): Essential for in-process testing and release testing of Sitagliptin batches to confirm they meet pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Stability Studies: Employed to track the formation and level of this impurity over time under various storage conditions.
• Research and Development (R&D): Used in synthetic chemistry research to study degradation pathways and to optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Sitagliptin Impurity
CAS No.	1152439-74-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sitagliptin Related Compound; Januvia 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; MK-0431 Impurity; 7-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]hexahydro-5-(trifluoromethyl)-[1,2,4]triazolo[4,3-a]pyrazine; Sitagliptin EP Impurity; Sitagliptin USP Impurity
EINECS	Contact for details

Quality Control

Our Sitagliptin Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation by techniques such as IR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (typically 15-25°C). For long-term stability, consider storage under inert atmosphere if the compound is easily oxidized. Keep the container tightly sealed in a dry environment to protect against moisture if hygroscopic.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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