Naloxone Hydrochloride Dihydrate USP

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Naloxone Hydrochloride Dihydrate USP

Naloxone Hydrochloride Dihydrate USP is an essential opioid antagonist used for the complete or partial reversal of opioid overdose. This highly effective pharmaceutical compound ensures immediate action, making it a critical tool in emergency medical situations.

Key Features and Specifications

Chemical CAS Number: 51481-60-8

Chemical Formula: C₁₉H₂₁NO₄•HCl•2H₂O

Chemical Formula Weight: F.W. 399.87

Assay (Dried Basis): 98.0-100.5%

Specific Rotation, [?]D25: -170° to -181°

Chloride Content (Dried Basis): 9.54-9.94%

Health Rating: 1

Flammability Rating: 1

Chemical Specifications

MAXIMUM LIMITS:
Noroxymorphone Hydrochloride and other Impurities: To pass test
Loss on Drying: 11.0%
Residual solvents: To pass test

Chemical Storage Information

This product is light sensitive; therefore, it should be kept tightly closed in light-resistant containers to maintain its efficacy and quality.

Manufacturing Standards

Naloxone Hydrochloride Dihydrate USP is produced under strict adherence to current Good Manufacturing Practices (cGMP) in compliance with 21CFR part 211 regulations, ensuring the highest quality and safety standards in FDA registered and inspected facilities.