Description

Milrinone Impurity 15 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 cardiovascular drug Milrinone. 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 for the identification and quantification of specific impurities in Milrinone Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Milrinone batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Used to track the formation of this impurity during forced degradation and long-term stability studies of Milrinone formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of Milrinone.

Basic Information

Product Name	Milrinone Impurity 15
CAS No.	156033-07-7
Molecular Formula	C12H9N3O
Molecular Weight	211.22 g/mol
Synonyms	1,6-Dihydro-2-methyl-6-oxo-[3,4'-bipyridine]-5-carbonitrile; 2-Methyl-5-cyano-1,6-dihydro-6-oxo-3,4'-bipyridine; Milrinone Related Compound; Milrinone Process Impurity; Milrinone Degradant
EINECS	Contact for details

Quality Control

Every batch of Milrinone Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and MS analyses.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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