Description

Sitagliptin Impurity 69 CAS NO 2172430-88-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of specific impurities during the development and manufacturing of Sitagliptin, a leading anti-diabetic drug. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on ensuring drug safety, efficacy, and regulatory compliance.

Application

• Primary use as a certified reference standard for analytical method development and validation in pharmaceutical QC/QA.
• Critical component for impurity profiling and characterization studies of Sitagliptin active pharmaceutical ingredient (API).
• Used in stability studies to track impurity formation and degradation pathways of drug substances and products.
• Essential for regulatory submissions (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Supports pharmaceutical research into the synthesis, metabolism, and pharmacokinetics of Sitagliptin and related compounds.
• Calibration standard for advanced analytical instrumentation including HPLC, UPLC, and LC-MS systems.

Basic Information

Product Name	Sitagliptin Impurity 69
CAS No.	2172430-88-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sitagliptin Related Compound 69; (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; Januvia Impurity 69; MK-0431 Impurity 69; Sitagliptin EP Impurity K; Sitagliptin USP Impurity; DPP-4 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Impurity 69 is manufactured and controlled under a strict quality management system. Our products undergo rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities. We support compliance with ICH Q3A/B, USP, and EP 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 (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccants or an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.