Naloxone HCl (Naloxone Hydrochloride) is a potent and specific opioid receptor antagonist recognized as the primary antidote in opioid overdose emergencies. Manufactured at Parand Darou Pharmaceutical Company in strict accordance with international standards (BP, USP), this Active Pharmaceutical Ingredient (API) plays a vital role in patient resuscitation and the critical management of opioid-induced intoxication.
Mechanism of Action & Clinical Indications
By rapidly binding to opioid receptors (predominantly the μ-receptor), Naloxone antagonizes and reverses life-threatening respiratory depression and central nervous system sedation within minutes. Possessing virtually no intrinsic agonist activity, it is exclusively indicated for the complete or partial reversal of opioid effects. The high purity of this product (Min. 99.2%) and tight assay tolerances ensure immediate onset of action and reliable patient safety in acute clinical settings.
Physicochemical Properties & Storage
Naloxone Hydrochloride is a white or almost white crystalline powder and is characteristically hygroscopic. It is freely soluble in water, soluble in ethanol (96%), and practically insoluble in toluene. Due to its sensitivity to environmental factors, the substance must be stored in airtight containers, protected from light, to maintain optimal stability and efficacy for at least 2 years at room temperature.
General Information
| Product Name | Naloxone HCl | |
| Chemical Name | 4,5α-Epoxy-3, 14-dihydroxy-17-(prop-2-enyl)morphinan-6-one hydrochloride dihydrate | |
| Manufacturer | Parand Darou Co. | |
| CAS No. | 51481-60-8 | |
| Category | Opioid overdose antidote | |
| Pharmacopoeia | BP, USP |
Specification
| Molecular formula | C19H22ClNO4, 2H2O | Sulfated ash | Max. 0.2% | |||
| Molecular weight | 399.9 | Content of chloride | 9.54%–9.94% on the dried basis. | |||
| Appearance | White or almost white, hygroscopic, crystalline powder | Purity | Min. 99.2% | |||
| Solubility | Freely soluble in water, soluble in ethanol (96%), practically insoluble in toluene | Assay | 98.0% to 102.0% (anhydrous substance) | |||
| Water | 7.5% to 11.0% | Storage | In an airtight container, protected from light | |||
| Specific optical rotation | -181 to -170 (anhydrous substance) | Stability | Stable at least 2 years at R.T |
