Naloxone Hydrochloride
Product name (5R,14S)-17-Allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one
monohydrochloride
Structure
Molecular Formula C19H21NO4·HCl
Molecular Weight 363.84
CAS Number 357-08-4
NMPA approval No. H20067738
National Drug standards YBH24672006
|
Test |
USP |
Results |
|
Color & Appearance |
white crystalline powder |
white crystalline powder |
|
Infrared spectrum |
consistent with the structure |
Conforms |
|
Assay (HPLC ) |
98.0 % ~100.5% |
99.9 % |
|
Noroxymorphone hydrochloride [(–)-4,5a-epoxy-3,14-dihydroxy -morphinan-6-one hydrochloride] and other impurities (TLC) |
NMT 1.0 % |
0.5% |
|
Specific rotation |
between﹣170 |
-175 |
|
Loss on Drying |
NMT 11.0% ( 105 ℃ ) |
9.0 % |
|
Chloride content |
9.54%～9.94% |
9.68% |
and ﹣181
Package: 1 kg
storage ：Preserve in tight, light-resistant containers. Store at 25℃.