Description

Milrinone Impurity 16 is a designated impurity of the pharmaceutical agent Milrinone, a cardiotonic and vasodilator. This compound is critical for analytical research and development, serving as a key reference standard for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control processes.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Milrinone API and finished dosage forms.
• Critical component in analytical method development and validation (e.g., HPLC, UPLC, LC-MS) for pharmaceutical quality control.
• Essential for stability studies and degradation pathway profiling of Milrinone.
• Used in regulatory compliance and submission to agencies like the FDA and EMA.
• Supports research and development of new synthetic routes and purification processes for Milrinone.
• Employed as a calibration standard in mass spectrometry and other spectroscopic techniques.

Basic Information

Product Name	Milrinone Impurity 16
CAS No.	2244529-59-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Milrinone Related Compound 16; Milrinone EP Impurity 16; Milrinone USP Impurity 16; 1,6-Dihydro-2-methyl-6-oxo-[3,4'-bipyridine]-5-carbonitrile; 2-Methyl-5-cyano-1,6-dihydro-6-oxo-3,4'-bipyridine; 4-(5-Cyano-4-methyl-6-oxo-1,6-dihydropyridin-3-yl)pyridine
EINECS	Contact for details

Quality Control

Our Milrinone Impurity 16 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and structural confirmation (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided to guarantee traceability and compliance with ICH guidelines.

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 Certificate of Analysis. The product should be kept in a dry environment and handled with appropriate laboratory safety practices.

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)	Complies
Residual Solvents (GC)	Complies with ICH limits

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