Naloxone HCl (Naloxone Hydrochloride) serves as a specific and vital opioid receptor antagonist, playing a critical role in medical emergencies and life-saving interventions. This Active Pharmaceutical Ingredient (API), manufactured at Parand Darou Pharmaceutical Company under the highest quality standards, is recognized as the first-line medication for the treatment and reversal of opioid overdose effects.
Mechanism of Action & Therapeutic Significance
Naloxone works through competitive binding to opioid receptors (particularly mu-receptors), rapidly neutralizing the effects of opioid agonists and effectively halting life-threatening respiratory depression. Parand Darou produces this compound with a purity of at least 99.2%, adhering strictly to BP and USP pharmacopoeial standards to ensure rapid and reliable efficacy in critical situations.
Quality Specifications, Stability & Storage
Naloxone HCl is formulated as a white, hygroscopic crystalline powder. It exhibits suitable stability when stored in an airtight, light-protected container and remains stable for at least 2 years at room temperature (R.T.). During the quality control process, precise assays for chloride content (9.54% to 9.94%) and water content tests (7.5% to 11.0%) are conducted to ensure full compliance with pharmaceutical grade requirements.
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 | Chloride content | 9.54%–9.94% (dried basis) | |||
| Appearance | White, hygroscopic, crystalline powder | Purity | Min. 99.2% | |||
| Solubility | Freely soluble in water; soluble in ethanol (96%); practically insoluble in toluene | Assay | 98.0%–102.0% (anhydrous) | |||
| Water | 7.5%–11.0% | Storage | In airtight, light-resistant container | |||
| Optical rotation | -181° to -170° (anhydrous) | Stability | Stable for at least 2 years at R.T |
