Description

Sitagliptin Impurity 7 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Sitagliptin. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in the research, development, and quality assurance processes for antidiabetic medications.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Sitagliptin API and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control (QC) Testing: A critical component in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of the API.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products during forced degradation and long-term stability studies of Sitagliptin.
• Research and Development: Used in R&D to study the degradation pathways, synthesis impurities, and overall impurity profile of Sitagliptin.

Basic Information

Product Name	Sitagliptin Impurity 7
CAS No.	1345822-88-9
Molecular Formula	C16H15F6N5O
Molecular Weight	407.31 g/mol
Synonyms	(3R)-3-Amino-4-(2,4,5-trifluorophenyl)-N-{[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]methyl}butanamide; (R)-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 7; Januvia Impurity 7; Sitagliptin EP Impurity G; Sitagliptin USP Impurity
EINECS	Contact for details

Quality Control

Our Sitagliptin Impurity 7 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) are provided, detailing results from comprehensive tests including HPLC purity, identification (IR, NMR), and residual solvent analysis.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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