Description

Levosimendan Impurity 10 is a designated reference standard used in the analytical profiling and quality control of the pharmaceutical agent Levosimendan. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a known 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 impurity standard for the identification and quantification of related substances in Levosimendan API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure API purity meets pharmacopeial (e.g., USP, EP) and internal specifications.
• Stability Studies: Employed to track the formation of degradation products in Levosimendan formulations under various stress conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of the API.

Basic Information

Product Name	Levosimendan Impurity 10
CAS No.	134678-47-0
Molecular Formula	C14H12N6O
Molecular Weight	280.28 g/mol
Synonyms	Simendan Impurity 10; (-)-[[4-(1,4,5,6-Tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl]hydrazono]propanedinitrile; (R)-(-)-[[4-(1,4,5,6-Tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl]hydrazono]propanedinitrile; Levosimendan Related Compound 10; OR-1896 Impurity
EINECS	Contact for details

Quality Control

Our Levosimendan Impurity 10 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided to support your regulatory and quality requirements.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

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

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