Description

Olprinone Impurity 24 is a specified impurity of Olprinone, a cardiotonic agent used in the treatment of acute heart failure. This reference standard is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require high-purity chemical standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Olprinone Impurity 24 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used to develop and optimize chromatographic methods, such as HPLC and UPLC, for impurity profiling of Olprinone.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency, adhering to ICH Q3A and Q3B guidelines.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization data.
• Stability Studies: Used as a marker to track the formation of degradation products in Olprinone drug substance and product under various stress conditions.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purer synthesis routes for Olprinone.

Basic Information

Product Name	Olprinone Impurity 24
CAS No.	116355-12-5
Molecular Formula	C₁₄H₁₀N₄O₂
Molecular Weight	266.25 g/mol
Synonyms	1,2-Dihydro-6-methyl-2-oxo-5-[imidazo[1,2-a]pyridin-6-yl]-3-pyridinecarbonitrile; 5-(Imidazo[1,2-a]pyridin-6-yl)-6-methyl-2-oxo-1,2-dihydropyridine-3-carbonitrile; Olprinone Related Compound; Olprinone EP Impurity; Olprinone Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Olprinone Impurity 24 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA), detailing identity, purity, and impurity profile, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white powder
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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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