Description

Levosimendan Impurity 2 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Levosimendan, a calcium sensitizer used in the treatment of acute decompensated heart failure. It is primarily required by pharmaceutical manufacturers and analytical laboratories for quality control, method development, and regulatory compliance. The compound is identified by the CAS Registry Number 103416-88-2.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of the drug substance Levosimendan.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Stability Studies: Employed to monitor the formation of this specific impurity in Levosimendan drug products under various storage conditions over time.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Levosimendan.
• Quality Assurance/Control (QA/QC) Testing: Routinely used in in-house QC laboratories to quantify impurity levels against established specifications.

Basic Information

Product Name	Levosimendan Impurity 2
CAS No.	103416-88-2
Molecular Formula	C14H12N6O
Molecular Weight	280.29 g/mol
Synonyms	[[(4R)-4-Methyl-6-oxo-1,4,5,6-tetrahydro-2,4'-bipyridine-3-carbonitrile]]; 2-[[(4R)-4-Methyl-6-oxo-1,4,5,6-tetrahydro-2,4'-bipyridin-3-yl]methylene]malononitrile; Levosimendan Related Compound B; (R)-2-((4-Methyl-6-oxo-1,4,5,6-tetrahydro-2,2'-bipyridin-3-yl)methylene)malononitrile; OR-1896 Impurity; Simdax Impurity
EINECS	Contact for details

Quality Control

Our Levosimendan Impurity 2 is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications and supporting its use as a pharmaceutical reference standard.

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 should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	Off-white to yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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