Description

Naloxone Hydrochloride is a potent, competitive opioid antagonist used to rapidly reverse the effects of opioid overdose. Its high pharmacological specificity and fast-acting nature make it a critical component in emergency medical care and harm reduction strategies worldwide. This active pharmaceutical ingredient (API) is essential for manufacturers of injectable solutions, nasal sprays, and auto-injectors targeting hospitals, emergency services, and community distribution programs.

Application

• Emergency Medicine: Primary API in injectable formulations (IV, IM, SC) for the emergency treatment of known or suspected opioid overdose in hospital and pre-hospital settings.
• Nasal Spray Production: Key ingredient in FDA-approved and other regulatory-approved nasal spray products designed for easy administration by first responders, caregivers, or individuals.
• Auto-injector Systems: Used in the manufacture of pre-filled, single-dose auto-injector devices for rapid, user-friendly administration in community overdose reversal programs.
• Pharmaceutical Research: Serves as a reference standard and tool compound in preclinical and clinical research studying opioid receptor pharmacology, addiction, and pain management.
• Veterinary Medicine: Employed in veterinary clinics to reverse opioid-induced respiratory depression in animals following surgical anesthesia or accidental exposure.
• Combination Drug Therapy: Used in fixed-dose combination products with opioids (e.g., buprenorphine/naloxone) to deter misuse while maintaining therapeutic efficacy for pain or addiction treatment.

Basic Information

Product Name	Naloxone Hydrochloride
CAS No.	357-08-4
Molecular Formula	C19H21NO4 • HCl
Molecular Weight	363.84 g/mol
Synonyms	Naloxone HCl; 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride; (-)-Naloxone hydrochloride; N-allylnoroxymorphone hydrochloride; EN-1530; Narcan (brand name component); Nalone; Narcanti
EINECS	206-614-0

Quality Control

Our Naloxone Hydrochloride is manufactured under strict quality management systems. It is typically tested to meet or exceed relevant pharmacopoeial standards such as USP, EP, and BP for critical parameters including identity, purity, and impurity profiles. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, heavy metals, and microbiological quality. We ensure full traceability and compliance with cGMP guidelines for API production.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or nitrogen purging to maintain stability.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Meets EP/USP criteria for non-sterile substances

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.