Description

Sitagliptin Impurity 46 is a high-purity 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 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: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurity profiles in drug master files (DMFs).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) as per ICH Q1A(R2).
• Research & Development: Used in synthetic chemistry R&D to study degradation pathways and optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Sitagliptin Impurity 46
CAS No.	1151240-94-6
Molecular Formula	C16H15F6N5O
Molecular Weight	407.31 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; Sitagliptin Related Compound 46; Sitagliptin EP Impurity 46; Sitagliptin USP Impurity 46; Januvia Impurity 46; MK-0431 Impurity 46; 1-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine
EINECS	Contact for details

Quality Control

Our Sitagliptin Impurity 46 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. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring compliance with ICH Q3A(R2) and ICH Q6A guidelines for impurities in new drug substances. Our standards are suitable for use in GMP/GLP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any single impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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