Description

Omarigliptin Impurity CAS NO 1819364-01-6 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Omarigliptin. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Omarigliptin API.
• Method Development & Validation: Essential for developing and validating robust HPLC, UPLC, or LC-MS analytical methods in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor and control impurity levels in commercial drug substance batches.
• Stability Studies: Employed to identify and track degradation products formed during forced degradation and long-term stability studies of Omarigliptin.
• Regulatory Submissions: Provides necessary data on impurity identity and characterization for regulatory filings (e.g., with FDA, EMA).
• Research & Development: Aids in understanding the degradation pathways and synthesis impurities of Omarigliptin during process development.

Basic Information

Product Name	Omarigliptin Impurity
CAS No.	1819364-01-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Omarigliptin Related Compound; Omarigliptin Process Impurity; Omarigliptin Degradant; MK-3102 Impurity; (2R,3S,5R)-2-(2,5-Difluorophenyl)-5-(2-methylsulfonyl-4,6-dihydro-3H-pyrrolo[3,4-c]pyrazol-5-yl)tetrahydro-3-furanyl amine impurity; 1819364-01-6; DPP-4 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Omarigliptin Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 COA. The material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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