MEDIOCON INC is a trusted global manufacturer and supplier of Naltrexone API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, formulation development, analytical testing, quality control, stability studies, and research applications. Every batch is manufactured under stringent quality management systems to ensure exceptional purity, consistency, and compliance with international pharmaceutical standards.
Naltrexone is a potent opioid receptor antagonist widely used in pharmaceutical formulations for the management of opioid dependence and alcohol use disorder. It works by competitively blocking opioid receptors, preventing the euphoric and sedative effects of opioid drugs while helping reduce alcohol cravings. Naltrexone is also investigated in low-dose formulations (LDN) for autoimmune diseases, chronic pain syndromes, inflammatory disorders, and neurological research. Owing to its well-established pharmacological profile, Naltrexone is extensively utilized in pharmaceutical research, formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.
MEDIOCON INC supplies premium-quality Naltrexone API to pharmaceutical manufacturers, formulation companies, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), universities, research institutes, and analytical laboratories worldwide. Comprehensive documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and regulatory support documents is available upon request.
| Parameter | Specification |
|---|---|
| Appearance | White to Off-White Crystalline Powder |
| Identification | IR, UV & HPLC Compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.50% |
| Residue on Ignition | NMT 0.10% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 4.5 – 6.5 |
| Individual Impurity | NMT 0.50% |
| Total Impurities | NMT 1.00% |
| Water Content | NMT 0.50% |
| Melting Point | 168°C – 172°C |
| Solubility | Freely soluble in methanol; slightly soluble in water and ethanol |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Naltrexone API Manufacturer & Supplier (CAS 16590-41-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Naltrexone API Manufacturer & Supplier is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.
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