Description

Milrinone Impurity 7 is a high-purity chemical 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 research institutions 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 & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Milrinone, adhering to ICH guidelines.
• Regulatory Compliance & Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity thresholds and demonstrate product safety.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies of Milrinone to understand its degradation pathways.
• Research & Development: Supports chemical and pharmacological R&D for studying the metabolism, synthesis pathways, and structure-activity relationships of Milrinone analogs.

Basic Information

Product Name	Milrinone Impurity 7
CAS No.	2250242-59-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Milrinone Related Compound 7; Milrinone EP Impurity G; Milrinone USP Impurity; 1,6-Dihydro-2-methyl-6-oxo-[3,4'-bipyridine]-5-carbonitrile; 2-Methyl-5-cyano-1,6-dihydro-6-oxo-3,4'-bipyridine
EINECS	Contact for details

Quality Control

Our Milrinone Impurity 7 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and impurity profiles. Our quality standards are designed to meet the requirements of pharmaceutical reference materials and support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 95.0%
Assay	≥ 97.0%
Related Substances (HPLC)	Meets acceptance criteria
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 1.0%

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