Description

Olprinone Impurity 2 is a designated reference standard used in the analytical profiling and quality control of the pharmaceutical active ingredient, Olprinone. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Serves as a critical impurity marker for the identification and quantification of related substances in Olprinone API and its formulations.
• Analytical Method Development & Validation: Used as a system suitability and calibration standard in HPLC, UPLC, and LC-MS methods to ensure analytical accuracy and precision.
• Quality Control & Batch Release Testing: Essential for routine impurity profiling to confirm that Olprinone drug substances and products meet stringent pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Compliance & Documentation: Provides necessary data for regulatory filings (e.g., ANDA, NDA) and supports compliance with FDA, EMA, and other global health authority requirements.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purer synthetic routes for Olprinone.

Basic Information

Product Name	Olprinone Impurity 2
CAS No.	106730-62-5
Molecular Formula	C₁₄H₁₀N₄O₂
Molecular Weight	266.26 g/mol
Synonyms	1,2-Dihydro-5-imidazo[1,2-a]pyridin-6-yl-6-methyl-2-oxo-3-pyridinecarbonitrile; Olprinone Related Compound B; Olprinone EP Impurity B; Olprinone USP Impurity; 6-Methyl-5-(6-imidazo[1,2-a]pyridinyl)-2(1H)-pyridinone-3-carbonitrile
EINECS	Contact for details

Quality Control

Every batch of Olprinone Impurity 2 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH and cGMP guidelines.

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 product 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 powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.