Description

Milrinone Impurity 2 is a specified impurity of the pharmaceutical active ingredient Milrinone, a cardiotonic agent. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Milrinone drug substances and products. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and analytical testing laboratories to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Milrinone API and finished dosage forms.
• Method Development and Validation: Essential for developing and validating analytical methods, particularly HPLC and LC-MS, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure impurity levels are within ICH (Q3B) specified limits.
• Stability Studies: Employed to track the formation of degradation products in Milrinone formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used to study and optimize synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Item	Detail
Product Name	Milrinone Impurity 2
CAS No.	400063-10-7
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 B; 2-Methyl-5-cyano-1,6-dihydro-6-oxo-[3,4'-bipyridine]; 2-Methyl-6-oxo-1,6-dihydro-[3,4'-bipyridine]-5-carbonitrile; 5-Cyano-1,6-dihydro-2-methyl-6-oxo-3,4'-bipyridine; Milrinone Impurity B; Milrinone EP Impurity B
EINECS	Contact for details

Quality Control

Our Milrinone Impurity 2 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards align with ICH Q3B guidelines for impurities in new drug substances, ensuring suitability for regulatory and pharmacopeial applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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