Naltrexone Hydrochloride (Naltrexone HCl) is a critical Active Pharmaceutical Ingredient (API) widely utilized in addiction therapy, specifically for the treatment and management of opioid and alcohol dependence. Synthesized and supplied by Parand Darou Co. under strict cGMP conditions, it complies with the latest monographs of BP and USP pharmacopoeias, offering high chemical purity (min. 99.0%). As a potent and long-acting opioid receptor antagonist, it plays an essential role in preventing relapse in detoxified patients.
Mechanism of Action & Clinical Indications
Naltrexone acts as a competitive antagonist at opioid receptors, exhibiting the highest affinity for mu (μ) receptors, and to a lesser extent, kappa (κ) receptors throughout the central nervous system. By blocking these receptors, it completely attenuates or blunts the euphoric and subjective effects of exogenous opioids. Furthermore, in the management of alcohol dependence, Naltrexone modulates the endogenous opioid system and dopaminergic pathways, significantly decreasing alcohol craving and the incidence of relapse.
Quality Attributes, Stability & Storage
Parand Darou supplies Naltrexone HCl as a white or almost white crystalline powder that is very hygroscopic. Its assay is strictly monitored within 98.0% to 102.0% on an anhydrous basis. Due to its sensitivity to moisture and light exposure, the material must be stored in tight, airtight containers protected from direct light. Under standard room temperature (R.T.) conditions, it maintains proven stability for at least 24 months.
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 basis) | |||
| Appearance | White or almost white powder, very hygroscopic | 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 | In an airtight container. Protected from light | |||
| Sulfated ash | Max. 0.1% | Stability | Stable at least 2 years at R.T |
