Naltrexone HCl (Naltrexone Hydrochloride) is a pure, long-acting opioid receptor antagonist utilized at the forefront of addiction therapy for opioid and alcohol dependence. This Active Pharmaceutical Ingredient (API) is manufactured at Parand Darou Pharmaceutical Company, adhering to the highest quality standards and compliant with international pharmacopoeias (BP, USP).
Mechanism of Action & Therapeutic Application
By competitively blocking μ-opioid and κ-opioid receptors, Naltrexone inhibits the euphoric effects of opioid consumption and prevents relapse post-detoxification. Furthermore, it regulates reward pathways in the central nervous system to control alcohol cravings. A synthesis purity of at least 99.0% and an assay range of 98.0% to 102.0% ensure the efficacy and safety of this product.
Physicochemical Properties & Storage Conditions
Naltrexone Hydrochloride powder is white or almost white and is very hygroscopic, with a maximum moisture content set at 10.0%. It is freely soluble in water. Due to its high sensitivity to environmental moisture and light, it must be stored in airtight, light-resistant containers to guarantee a 2-year stability period.
General Information
| Product Name | Naltrexone HCl | |
| Chemical Name | 17-(Cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride | |
| Manufacturer | Parand Darou Co. | |
| CAS No. | 850808-02-5 | |
| Category | Addiction therapy | |
| Pharmacopoeia | BP, USP |
Specification
| Molecular formula | C20H24ClNO4 | Ethanol | Max. 3.0% | |||
| Molecular weight | 377.9 | Content of chloride | 9.20%–9.58% (anhydrous/solvent-free) | |||
| Appearance | White or almost white, very hygroscopic powder | Residue on ignition | Max. 0.1% | |||
| Solubility | Freely soluble in water, slightly soluble in ethanol (96%), practically insoluble in methylene chloride | Purity | Min. 99.0% | |||
| Water | Max. 10.0% | Assay | 98.0% to 102.0% (anhydrous substance) | |||
| Specific optical rotation | -187 to -195 (anhydrous substance) | Storage | Airtight, protected from light | |||
| Sulfated ash | Max. 0.1% | Stability | Stable at least 2 years at R.T |
