Description

Naloxone Hydrochloride Dihydrate is the dihydrate salt form of the opioid receptor antagonist, naloxone. This high-purity pharmaceutical active ingredient is critical for the formulation of life-saving opioid overdose reversal medications. It is essential for manufacturers in the pharmaceutical and biotechnology sectors developing injectable solutions, nasal sprays, and auto-injectors. The compound's reliable antagonistic action makes it a cornerstone in emergency medical treatments and harm reduction programs worldwide.

Application

• Active Pharmaceutical Ingredient (API) in emergency injectable formulations for opioid overdose reversal.
• Key component in the manufacture of FDA-approved nasal spray products (e.g., Narcan®).
• Used in the production of pre-filled auto-injectors and emergency response kits.
• Essential raw material for clinical research and development of new opioid antagonist therapies.
• Reference standard in analytical laboratories for quality control and forensic testing.
• Formulation studies for novel drug delivery systems targeting rapid bioavailability.

Basic Information

Product Name	Naloxone Hydrochloride Dihydrate
CAS No.	51481-60-8
Molecular Formula	C₁₉H₂₁NO₄ • HCl • 2H₂O
Molecular Weight	399.86 g/mol
Synonyms	Naloxone HCl Dihydrate; 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride dihydrate; (-)-Naloxone hydrochloride dihydrate; N-allylnoroxymorphone hydrochloride dihydrate; EN-1530; Narcan (as the hydrochloride salt); Nalorex; Narcanti
EINECS	Contact for details

Quality Control

Our Naloxone Hydrochloride Dihydrate is manufactured and tested to meet stringent pharmaceutical-grade standards. Quality assurance protocols are designed to ensure compliance with relevant pharmacopoeial monographs (e.g., USP, EP). Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, ensuring traceability and reliability for critical drug manufacturing.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is hygroscopic (moisture-sensitive) and must be protected from excessive humidity to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC, anhydrous basis)	98.0% - 102.0%
Water Content (KF)	7.0% - 9.5%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	< 20 ppm

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