Description

Dantrolene Sodium is a direct-acting skeletal muscle relaxant that works by inhibiting calcium release from the sarcoplasmic reticulum. This mechanism makes it a critical pharmaceutical active ingredient for managing conditions associated with hypermetabolic skeletal muscle activity. It is primarily utilized in the formulation of injectable and oral medications within the pharmaceutical industry. Dantrolene Sodium CAS NO 24868-20-0 is essential for producing treatments for malignant hyperthermia and muscle spasticity.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the manufacture of injectable solutions for the emergency treatment of malignant hyperthermia.
• Oral Medication Formulation: Key component in capsules or tablets for the chronic management of muscle spasticity associated with spinal cord injuries, stroke, cerebral palsy, or multiple sclerosis.
• Hospital Emergency Stock: An essential drug for hospital pharmacies and surgical centers to have on hand for anesthesia-related emergencies.
• Veterinary Medicine: Used in equine and other veterinary practices for the treatment of exertional rhabdomyolysis (tying-up syndrome) and similar hypermetabolic conditions in animals.
• Research & Development: Serves as a crucial pharmacological tool in biomedical research for studying calcium signaling, muscle physiology, and neuromuscular disorders.

Basic Information

Product Name	Dantrolene Sodium
CAS No.	24868-20-0
Molecular Formula	C14H9N4NaO5
Molecular Weight	336.24 g/mol
Synonyms	Dantrolene Sodium Salt; 1-[[5-(4-Nitrophenyl)-2-furanyl]methylene]amino]-2,4-imidazolidinedione Sodium Salt; Dantrium; Dantamacrin; Dantrolen; F-368; Sodium Dantrolene; Dantrolene Sodique; Dantrolenum Natricum
EINECS	246-469-1

Quality Control

Our Dantrolene Sodium is manufactured and tested to meet stringent pharmaceutical standards. Quality assurance protocols are designed to ensure identity, purity, strength, and composition. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological attributes. We adhere to current Good Manufacturing Practices (cGMP) and support compliance with major pharmacopoeial standards such as USP and EP.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	Yellow to orange-yellow, fine powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Total aerobic microbial count ≤ 1000 cfu/g Total combined yeasts/molds ≤ 100 cfu/g
Specified Microorganisms	Absence of E. coli, Salmonella, S. aureus, P. aeruginosa

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