Description

Milrinone Impurity CAS NO 111463-11-7 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Milrinone, a cardiotonic agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material to identify, quantify, and control this specific impurity in Milrinone API batches.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods for Milrinone analysis.
• Quality Control & Assurance (QC/QA): Employed in in-house quality control laboratories to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Stability Studies: Used to track the formation and level of this impurity during forced degradation and long-term stability studies of Milrinone formulations.
• Research & Development: Utilized in pharmaceutical R&D for studying the degradation pathways and metabolism of Milrinone.

Basic Information

Product Name	Milrinone Impurity
CAS No.	111463-11-7
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; 2-Methyl-5-cyano-1,6-dihydro-6-oxo-[3,4'-bipyridine]; Milrinone EP Impurity; Milrinone USP Impurity; 6-Oxo-1,6-dihydro-[3,4'-bipyridine]-5-carbonitrile, 2-methyl-; 111463-11-7
EINECS	Contact for details

Quality Control

Our Milrinone Impurity is manufactured under strict quality systems to meet the exacting standards of pharmaceutical analysis. Each batch is rigorously tested using validated methods, including HPLC for purity and identity confirmation via spectroscopic techniques. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with ICH Q3A(R2) and Q3B(R2) guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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