Description

Olprinone Impurity 3 is a designated reference standard used for the analytical profiling and quality control of the pharmaceutical active ingredient Olprinone. This impurity is critical for ensuring the purity, safety, and efficacy of the final drug product by providing a benchmark for identification and quantification during manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) involved in the development and production of Olprinone-based cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for calibrating analytical instruments and validating testing methods.
• Method Development and Validation: Used in developing and qualifying High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods for impurity profiling.
• Quality Control and Batch Release: Essential for the routine testing of active pharmaceutical ingredients (APIs) and finished drug products to monitor and control impurity levels against established specifications.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity identification, characterization, and control strategies as per ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity over time under various storage conditions, ensuring product shelf-life.
• Research and Development: Used in synthetic chemistry research to understand degradation pathways and to develop robust purification processes for the main API.

Basic Information

Product Name	Olprinone Impurity 3
CAS No.	1402751-73-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1,2-Dihydro-6-methyl-2-oxo-5-(imidazo[1,2-a]pyridin-6-yl)-3-pyridinecarbonitrile; Olprinone Related Compound C; Olprinone EP Impurity C; Olprinone Process Impurity; 5-(Imidazo[1,2-a]pyridin-6-yl)-6-methyl-2-oxo-1,2-dihydropyridine-3-carbonitrile
EINECS	Contact for details

Quality Control

Our Olprinone Impurity 3 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets high-purity standards suitable for use as a reference material. Certificates of Analysis (COA) detailing batch-specific results are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The container should be kept securely sealed to protect the integrity of the material.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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