Description

Milrinone Related Compound A (50 Mg) (1,6-Dihydro-2-Methyl-6-Oxo(3,4'-Bipyridine)-5-Car-Boxamide) is a high-purity chemical reference standard of a key impurity and degradation product of the cardiac inotropic agent Milrinone. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical formulations through rigorous analytical testing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and regulatory affairs teams for method development, validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific related substance in Milrinone Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies and Forced Degradation Testing: Employed to understand the degradation pathways of Milrinone and to establish shelf-life specifications for drug products.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure every batch of Milrinone API meets stringent pharmacopeial (e.g., USP, EP) or in-house purity specifications.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research into Metabolites and Degradation Pathways: Used in academic and industrial research to study the chemical behavior and pharmacokinetics of Milrinone and its analogs.

Basic Information

Item	Details
Product Name	Milrinone Related Compound A (50 Mg) (1,6-Dihydro-2-Methyl-6-Oxo(3,4'-Bipyridine)-5-Car-Boxamide)
CAS No.	80047-24-1
Molecular Formula	C12H11N3O2
Molecular Weight	229.24 g/mol
Synonyms	1,6-Dihydro-2-methyl-6-oxo-[3,4'-bipyridine]-5-carboxamide; 2-Methyl-5-carbamoyl-1,6-dihydro-6-oxo-3,4'-bipyridine; Milrinone Impurity A; Milrinone EP Impurity A; Milrinone Related Substance A; WIN 47203 Related Compound A; 3,4'-Bipyridine-5-carboxamide, 1,6-dihydro-2-methyl-6-oxo-
EINECS	Contact for details

Quality Control

Every batch of Milrinone Related Compound A is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identity confirmation (IR, NMR), purity assay (HPLC), and control of specific impurities, to ensure it meets the exacting standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each lot, confirming compliance with specified criteria and supporting its use in GMP/GLP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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