Description

Levosimendan Impurity 14 is a specified impurity of the inotropic agent Levosimendan, identified by CAS No. 144238-75-5. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of the active pharmaceutical ingredient (API). It is essential for professionals in pharmaceutical manufacturing, analytical laboratories, and regulatory affairs who require high-purity chemical standards to ensure drug safety, efficacy, and compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Levosimendan API and finished drug products.
• Analytical Method Development & Validation: Crucial for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Levosimendan meets stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to establish drug shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic route optimization and process chemistry studies to understand and minimize impurity formation.

Basic Information

Product Name	Levosimendan Impurity 14
CAS No.	144238-75-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(-)-[[4-(1,4,5,6-Tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl]hydrazono]propanedinitrile; Levosimendan Related Compound; Simendan Impurity; (R)-(-)-Simendan Impurity; 2-[[4-[(Z)-(2,3-Dicyano-2-propenylidene)amino]phenyl]hydrazono]-3-methyl-5-pyrazolone
EINECS	Contact for details

Quality Control

Every batch of Levosimendan Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with industry and regulatory standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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	Off-white to yellow solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.