Description

Milrinone Impurity 5 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. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Milrinone API and finished drug products.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control & Assurance: Serves as a system suitability standard in QC labs to monitor the performance of chromatographic assays for Milrinone.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive characterization data for specified impurities.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in pharmacokinetic, metabolic, and toxicological studies to understand the profile of Milrinone-related substances.

Basic Information

Product Name	Milrinone Impurity 5
CAS No.	1443528-66-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1,6-Dihydro-2-methyl-6-oxo-[3,4'-bipyridine]-5-carbonitrile; Milrinone Related Compound; Milrinone Specified Impurity; Milrinone Process Impurity; Milrinone Degradant; 2-Methyl-5-cyano-1,6-dihydro-6-oxo-3,4'-bipyridine
EINECS	Contact for details

Quality Control

Our Milrinone Impurity 5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment to ensure traceability and compliance with ICH Q3A/B guidelines for pharmaceutical 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 at 2-8°C. Handle the material under inert conditions if specified to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with individual specification
Residual Solvents (GC)	Complies with ICH Q3C

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