Description

Sitagliptin Impurity Sky-Iv is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Sitagliptin. This compound is critical for ensuring the safety and efficacy of pharmaceutical formulations by enabling the accurate identification and quantification of specific process-related impurities. It is an essential material for analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Sitagliptin Impurity Sky-Iv in Sitagliptin API and finished drug products.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS).
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with International Council for Harmonisation (ICH) Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Sitagliptin formulations.
• Research & Development: Facilitates process chemistry research aimed at understanding impurity formation pathways and optimizing synthesis routes to minimize its presence.

Basic Information

Product Name	Sitagliptin Impurity Sky-Iv
CAS No.	486459-88-5
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; Sky-Iv Impurity; Sitagliptin Related Compound Sky-Iv; Januvia Impurity Sky-Iv; MK-0431 Impurity Sky-Iv; Sitagliptin EP Impurity G; Sitagliptin Process Impurity
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Each batch of Sitagliptin Impurity Sky-Iv is characterized and qualified using advanced analytical techniques to guarantee identity, purity, and stability. Certificates of Analysis (COA) are available upon request, providing detailed results from tests including HPLC purity, residual solvent analysis, and spectroscopic identification. Our quality system is designed to support compliance with cGMP and relevant pharmacopeial guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. Keep the container tightly sealed in a cool, dry, and well-ventilated place.

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%
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.