Description

Dantrolene Related Compound A (5-(4-Nitrophenyl)-2-Furaldehyde Azine) is a high-purity analytical reference standard essential for pharmaceutical research and quality control. This compound serves as a critical impurity marker and system suitability standard in the analysis of Dantrolene Sodium, a muscle relaxant. It is primarily required by analytical chemists, quality assurance laboratories, and research institutions involved in method development, validation, and regulatory compliance testing. The 50 mg quantity is ideal for precise laboratory use, ensuring reliable and reproducible results in chromatographic and spectroscopic analyses.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of related substances in Dantrolene Sodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods to meet ICH Q2(R1) and USP guidelines.
• Quality Control (QC) Testing: Employed in routine QC laboratories as a system suitability standard to ensure the performance and specificity of analytical procedures for Dantrolene.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to monitor the formation of specific impurities over time.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and demonstrate control strategies for the drug substance.
• Research & Development: Utilized in metabolic and pharmacokinetic studies to understand the degradation pathways of Dantrolene.

Basic Information

Product Name	Dantrolene Related Compound A (50 Mg) (5-(4-Nitrophenyl)-2-Furaldehyde Azine)
CAS No.	301359-05-7
Molecular Formula	C22H14N4O5
Molecular Weight	414.37 g/mol
Synonyms	5-(4-Nitrophenyl)-2-furaldehyde azine; Dantrolene Impurity A; Dantrolene Related Substance A; Azine of 5-(p-Nitrophenyl)-2-furaldehyde; 1,2-Bis[5-(4-nitrophenyl)-2-furyl]diazene 1,2-dioxide; Dantrolene EP Impurity A; Dantrolene Sodium Related Compound A; (E,E)-1,2-Bis(5-(4-nitrophenyl)furan-2-yl)diazene 1,2-dioxide
EINECS	Contact for details

Quality Control

Every batch of Dantrolene Related Compound A is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR), to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and impurity profile. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	Yellow to orange-yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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