Description

Levosimendan Impurity 8 is a designated chemical reference standard used in the analytical profiling and quality control of the cardiovascular drug Levosimendan. This high-purity impurity is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance. It serves as an essential tool for method development, validation, and stability studies within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Levosimendan Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Crucial for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to confirm the purity of Levosimendan and to ensure it meets pharmacopeial specifications (e.g., ICH guidelines).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic chemistry research aimed at understanding and minimizing impurity formation during the manufacturing process.

Basic Information

Product Name	Levosimendan Impurity 8
CAS No.	274263-65-9
Molecular Formula	C14H12N6O
Molecular Weight	280.29 g/mol
Synonyms	6-[(4R)-4-Methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl]-5-methyl-4,5-dihydro-3(2H)-pyridazinone; (R)-6-(4-Methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)-5-methyl-4,5-dihydro-3(2H)-pyridazinone; Levosimendan Related Compound 8; Simdax Impurity 8; UNII-7K3I4B6W4P
EINECS	Contact for details

Quality Control

Every batch of Levosimendan Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 (HPLC)	Retention time matches reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
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.