Description

Sitagliptin Impurity 22 CAS NO 945261-50-7 is a high-purity chemical reference standard specifically identified as a process-related impurity of the active pharmaceutical ingredient Sitagliptin. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this specific impurity during drug manufacturing. It is an essential tool for analytical chemists and quality control professionals in the pharmaceutical industry who require reliable standards to ensure product safety, efficacy, and regulatory compliance for antidiabetic medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Sitagliptin and related drug substances.
• Method Development and Validation: Crucial for developing and validating robust analytical methods (e.g., HPLC, UPLC, LC-MS) for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing of Sitagliptin API to monitor and control impurity levels against ICH guidelines.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity identification and characterization data.
• Stability Studies: Employed to track the formation and level of this impurity in Sitagliptin formulations under various stability-indicating conditions.
• Research and Development (R&D): Facilitates process chemistry research aimed at understanding and minimizing impurity formation during API synthesis.

Basic Information

Product Name	Sitagliptin Impurity 22
CAS No.	945261-50-7
Molecular Formula	C16H15F6N5O
Molecular Weight	407.32 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 22; Sitagliptin EP Impurity J; Januvia Impurity 22; MK-0431 Impurity 22; Sitagliptin Process Impurity; 7-[(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

Every batch of Sitagliptin Impurity 22 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, LC-MS, NMR) 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. Our quality commitment aligns with ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere such as argon or nitrogen.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%
Heavy Metals	≤ 20 ppm

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