Description

Dantrolene is a direct-acting skeletal muscle relaxant, specifically a ryanodine receptor antagonist. This compound is of critical importance for its unique mechanism of action, which inhibits the release of calcium ions from the sarcoplasmic reticulum in muscle cells. It is primarily required by the pharmaceutical industry for the formulation of injectable and oral medications, serving as a vital therapeutic agent for the management of malignant hyperthermia and chronic spasticity.

Application

• Pharmaceutical Active Ingredient (API): The primary use is as the active pharmaceutical ingredient in medications for malignant hyperthermia, a life-threatening condition triggered by certain anesthetics.
• Muscle Spasticity Treatment: Formulated into oral dosage forms for the long-term management of muscle spasticity associated with conditions such as spinal cord injury, stroke, cerebral palsy, and multiple sclerosis.
• Neuromuscular Research: Used as a critical research tool in biochemical and pharmacological studies to investigate calcium signaling, muscle contraction mechanisms, and ryanodine receptor function.
• Veterinary Medicine: Applied in veterinary practice for the treatment of malignant hyperthermia in susceptible animal breeds, particularly swine.
• Reference Standard: Serves as a high-purity chemical reference standard for quality control and analytical method development in pharmaceutical laboratories.

Basic Information

Product Name	Dantrolene
CAS No.	85008-71-5
Molecular Formula	C14H10N4O5
Molecular Weight	314.25 g/mol
Synonyms	Dantrolene Sodium (common salt form); 1-[[[5-(4-Nitrophenyl)-2-furanyl]methylene]amino]-2,4-imidazolidinedione; Dantrium (trade name); Ryanodex (trade name); Dantrolen; F-368
EINECS	285-223-8

Quality Control

Our Dantrolene is manufactured and tested to meet stringent pharmacopeial standards, including USP and EP monographs where applicable. Every batch undergoes comprehensive analytical testing for identity, purity, and potency. Certificates of Analysis (COA) documenting results for assay, related substances, residual solvents, and other critical parameters are provided to ensure full traceability and compliance with cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	Orange-yellow, fine crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF Titration)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5%; Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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