Description

Levosimendan Impurity 1 is a specified impurity and reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Levosimendan. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Levosimendan API batches.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): A critical component in routine quality control testing to monitor and control impurity levels according to ICH Q3A/B guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing necessary impurity characterization data for agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.

Basic Information

Product Name	Levosimendan Impurity 1
CAS No.	1643439-59-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Levosimendan Related Compound 1; Levosimendan Specified Impurity 1; (R)-[[4-(1,4,5,6-Tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl]hydrazono]propanedinitrile; Simendan Impurity 1; CAS 1643439-59-1; Levosimendan Process Impurity; Levosimendan Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Levosimendan Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, impurities, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to Off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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