Description

Milrinone Impurity 3 is a specified impurity and degradation product of the pharmaceutical agent Milrinone, a cardiotonic agent used in the treatment of heart failure. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Milrinone drug substances and products.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Milrinone Active Pharmaceutical Ingredient (API).
• Essential for analytical method development and validation (e.g., HPLC, UPLC, GC) in quality control laboratories.
• Critical component in stability studies and forced degradation studies to profile degradation pathways of Milrinone.
• Used for regulatory compliance and submissions to agencies like the FDA and EMA, supporting drug approval processes.
• Serves as a research tool in pharmacokinetic and metabolic studies of Milrinone.
• Employed in the calibration of analytical equipment to ensure accurate and reproducible impurity detection.
• Used by contract research organizations (CROs) and testing laboratories offering pharmaceutical analysis services.
• Supports the manufacture of high-purity Milrinone by providing a benchmark for impurity control during synthesis and purification.

Basic Information

Product Name	Milrinone Impurity 3
CAS No.	98293-81-3
Molecular Formula	C12H9N3O
Molecular Weight	211.22 g/mol
Synonyms	1,6-Dihydro-2-methyl-6-oxo-[3,4'-bipyridine]-5-carbonitrile; Milrinone Related Compound C; 2-Methyl-5-cyano-1,6-dihydro-6-oxo-3,4'-bipyridine; Milrinone EP Impurity C; Milrinone USP Impurity C; 6-Oxo-1,6-dihydro-2-methyl-3,4'-bipyridine-5-carbonitrile; Milrinone Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Milrinone Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results from advanced chromatographic and spectroscopic analyses. Our quality commitment aligns with the needs of GMP/GLP-compliant environments, supporting global regulatory requirements.

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 light-sensitive (store away from light). Keep the container in a dry, cool, and well-ventilated area. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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