Description

Levosimendan Impurity CAS NO 139052-02-1 is a high-purity reference standard used in the analytical profiling and quality control of the cardiovascular drug Levosimendan. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods for Levosimendan API and finished dosage forms.
• Quality Control & Assurance (QC/QA): Essential for impurity profiling, batch release testing, and ensuring Levosimendan drug products meet stringent pharmacopeial specifications (e.g., USP, EP).
• Research & Development (R&D): Used in degradation studies, forced degradation, and stability-indicating method development to understand the drug's behavior under various conditions.
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary data on impurity identification and qualification as per ICH Q3A and Q3B guidelines.
• Method Development & Validation: A key component in developing and validating precise HPLC, UPLC, or LC-MS methods for the analysis of Levosimendan and its related compounds.

Basic Information

Product Name	Levosimendan Impurity
CAS No.	139052-02-1
Molecular Formula	C14H12N6O
Molecular Weight	280.28 g/mol
Synonyms	[[(4R)-4-Methyl-6-oxo-1,4,5,6-tetrahydro-3-pyridazinyl]hydrazono]propanedinitrile; Levosimendan Related Compound; (R)-2-[[4-(1,4,5,6-Tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl]hydrazono]propanedinitrile; 2-[[4-[(4R)-1,4,5,6-Tetrahydro-4-methyl-6-oxo-3-pyridazinyl]phenyl]hydrazono]propanedinitrile; Levosimendan Impurity A; Levosimendan EP Impurity A
EINECS	Contact for details

Quality Control

Every batch of Levosimendan Impurity CAS NO 139052-02-1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, 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). This material is hygroscopic (moisture-sensitive) and easily oxidized; it is recommended to store the container under an inert atmosphere (e.g., nitrogen or argon) after opening to ensure long-term stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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