Description

Dantrolene Related Compound B (50 Mg) (5-(4-Nitrophenyl)-2-Furaldehyde-(2-Carboxymethyl) Semicarbazone) is a high-purity analytical reference standard, specifically identified as a related substance of the skeletal muscle relaxant Dantrolene Sodium. This compound is critical for pharmaceutical research and development, serving as a key marker for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API). It is primarily utilized by analytical chemists, quality control laboratories, and regulatory affairs professionals in the pharmaceutical industry for method development, validation, and impurity profiling in compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of Dantrolene Sodium impurities in accordance with ICH Q3A/B guidelines.
• Analytical Method Development and Validation: Used as a system suitability standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for Dantrolene Sodium analysis.
• Quality Control and Batch Release Testing: Essential for routine QC testing in API and finished drug product manufacturing to monitor impurity levels and ensure batch-to-batch consistency.
• Stability Studies and Forced Degradation Testing: Employed as a reference marker to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the manufacturing process and product quality.
• Research and Development: Used in preclinical and clinical research to understand the metabolism and degradation pathways of Dantrolene Sodium.

Basic Information

Product Name	Dantrolene Related Compound B (50 Mg) (5-(4-Nitrophenyl)-2-Furaldehyde-(2-Carboxymethyl) Semicarbazone)
CAS No.	57268-33-4
Molecular Formula	C₁₅H₁₂N₄O₆
Molecular Weight	344.28 g/mol
Synonyms	5-(4-Nitrophenyl)-2-furaldehyde (2-carboxymethyl)semicarbazone; Dantrolene Impurity B; Dantrolene Related Substance B; Dantrolene EP Impurity B; Dantrolene Sodium Related Compound B; 5-(p-Nitrophenyl)furfural N-(carboxymethyl)carbamoylhydrazone; (5-(4-Nitrophenyl)furan-2-yl)methylene amino(2-oxoethyl)carbamate
EINECS	Contact for details

Quality Control

Every batch of Dantrolene Related Compound B is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, NMR, and Mass Spectrometry to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each unit, supporting compliance with cGMP and relevant pharmacopeial monographs (USP, EP).

Storage

Preserve in the original, tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	Yellow to orange-yellow powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
Heavy Metals	≤ 20 ppm

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