Description

Levosimendan Impurity 16 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient, Levosimendan. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control. The material is essential for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Levosimendan API and finished drug products.
• Analytical Method Development & Validation: A critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Used to track the formation and behavior of this specific impurity under various stress conditions (e.g., heat, light, humidity).
• Research & Development (R&D): Facilitates studies on the synthesis pathway, degradation profile, and toxicological assessment of Levosimendan-related substances.

Basic Information

Item	Details
Product Name	Levosimendan Impurity 16
CAS No.	2290570-69-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Levosimendan Related Compound 16; Levosimendan EP Impurity J; Levosimendan USP Impurity; (-)-[[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; Simendan Impurity 16
EINECS	Contact for details

Quality Control

Our Levosimendan Impurity 16 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, identity confirmation (by IR/LC-MS), and residual solvent analysis to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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