Swapnroop Drugs & Pharmaceuticals offers Bretylium Tosylate API for pharmaceutical and research applications. Bretylium Tosylate is a quaternary ammonium compound supplied as the tosylate salt and is associated with antiarrhythmic and adrenergic-blocking activity.
Bretylium Tosylate is the p-toluenesulfonate salt of bretylium. It is chemically classified as a quaternary ammonium salt and organosulfonate. The compound is known for inhibiting norepinephrine release from peripheral sympathetic nerve terminals.
Bretylium Tosylate has been used as an antiarrhythmic agent, particularly in the management of serious ventricular arrhythmias. It has also been studied for its adrenergic-blocking and sympathetic nervous system effects.
Bretylium Tosylate is described as a white to off-white, hygroscopic crystalline powder. Published pharmaceutical references report a melting range around 96–99°C or approximately 97–99°C. It is freely soluble in water, alcohol and methanol and is practically insoluble in ether, ethyl acetate and hexane.
Identification of Bretylium Tosylate can be performed using analytical techniques including infrared spectroscopy and chromatographic methods. Published analytical literature describes HPLC methods for quantitative determination of Bretylium Tosylate in raw material and pharmaceutical preparations.
For pharmaceutical manufacturing and quality-control applications, appropriate testing can include identification, assay, loss on drying, residue on ignition, heavy metals, impurities, water content, pH of an aqueous solution, melting point and solubility.
Bretylium Tosylate is hygroscopic. Pharmaceutical references describe storage in airtight containers and protection from light; a historical pharmacopoeial reference specifies storage at or below 25°C, with permitted excursions between 15°C and 30°C.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR / HPLC |
| Assay (HPLC) | NLT 98.0% |
| Loss on Drying | NMT 4.5% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 4.5 – 7.0 |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 4.5% |
| Melting Point | 96 – 99°C |
| Solubility | Freely soluble in water, alcohol and methanol; practically insoluble in ether, ethyl acetate and hexane |