MEDIOCON INC is a trusted global manufacturer and supplier of Nalfurafine 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.
Nalfurafine is a highly selective kappa-opioid receptor (KOR) agonist widely used in pharmaceutical formulations and research for the treatment of uremic pruritus (itching associated with chronic kidney disease) and other refractory pruritic conditions. Unlike conventional opioid agonists, Nalfurafine selectively activates kappa-opioid receptors, helping alleviate severe itching while minimizing the risk of dependence and respiratory depression. It is also extensively utilized in neuroscience research, receptor pharmacology studies, formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.
MEDIOCON INC supplies premium-quality Nalfurafine 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 | 198°C – 204°C |
| Solubility | Slightly soluble in water; soluble in methanol and ethanol |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Nalfurafine API Manufacturer & Supplier (CAS 152657-84-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Nalfurafine 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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