Description

Sitagliptin Defluoro Impurity 4 is a high-purity reference standard used in the pharmaceutical development and quality control of Sitagliptin, a leading anti-diabetic medication. This compound is critical for the accurate identification, quantification, and monitoring of a specific process-related impurity, ensuring the final drug product meets stringent regulatory purity requirements. It is an essential material for analytical laboratories, quality assurance departments, and research scientists working in pharmaceutical manufacturing and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation in Sitagliptin API and formulation analysis.
• Impurity Profiling and Control: Used to establish and monitor impurity limits in accordance with ICH Q3A(R2) and Q3B(R2) guidelines for new drug substances and products.
• Quality Control (QC) Testing: Serves as a system suitability and identification standard in routine HPLC and LC-MS testing of Sitagliptin batches.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions during drug product shelf-life studies.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in process chemistry research to understand and optimize synthesis pathways to minimize impurity formation.

Basic Information

Product Name	Sitagliptin Defluoro Impurity 4
CAS No.	486459-98-7
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; Desfluoro Sitagliptin Impurity 4; Sitagliptin EP Impurity D; Sitagliptin USP Related Compound D; Januvia Impurity D; MK-0431 Impurity D
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Defluoro Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

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

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