Dextromethorphan hydrobromide monohydrate/CAS:6700-34-1
Product Name:Dextromethorphan hydrobromide monohydrate
Synonyms:dextromethorphansigmareference*standard;DMHM;D-3-METHOXY-N-METHYLMORPHINAN HYDROBROMIDE;DEXTROMETHORPHAN HYDROBROMIDE;DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE;DEXTROMETHORPHAN HYDROBROMIDE, PH EUR;DEXTROMETHORPHAN HYDROBROMIDE*MONOHYDRAT E USP;D-Methorphan hydrobromide monohydrate
CAS:6700-34-1
MF:C18H28BrNO2
MW:370.32
mp:116-119°C
Fp:11 °C
Chemical Properties:White Solid
Usage:An antitussive drug. Orally active synthetic morphine analog. Analgesic. Racemethorphan and levomethorpham are controlled substances (opiates).
Biological Activity,Non-competitive, low affinity NMDA receptor antagonist. Antitussive, anticonvulsive and neuroprotective agent.
Dextromethorphan hydrobromide monohydrate Introduction
Dextromethorphan non-narcotic drugs, is central antitussive, can be used for acute dry cough or spasmodic cough as the main symptoms of respiratory tract infection, acute or chronic bronchitis and other respiratory diseases [1-2] ʱ?? Orally disintegrating tablets means that you can quickly disintegrate in the oral cavity, dispersed or dissolved in saliva tablets, is the rapid development of new solid preparation together abroad in recent years. Dextromethorphan hydrobromide oral disintegrating tablets can be taken without water when swallowing assist in the rapid disintegration in the oral cavity tens of seconds into fine particles, only a few swallowing medication to complete the process, especially for the water not convenient place and are difficult to swallow.
TESTSPECIFICATIONTEST RESULT
01ApperancePractically white crystal or crystalline powderWhite crystalline powder
02IdentificationA. FT-IRThe sample spectrum correspond to that of the reference standardConforms
B. UVNot more than 3.0% difference of RS（on anhydrous basis）1.4%
C. Bromide TestYellow white precipitate formedConforms
03Specific rotation A1.8w/v in water:Not more than 1.0%difference of RS At 325nm and 25℃(on anhydrous basis) 0.23%
04Specific rotation B2.0%w/v in 0.1M HCL: +28℃to +30℃ at 589nm and 20℃(on anhydrous basis) +28.2℃
05Clarity of solution5.0%w/v in alcohol:Clear and colorlessConforms
06PH5.2-6.5（1 in 100 water solution）6.1
07Acidity or AlkalinityNot more than 0.4ml of 0.01M HCLconsumed0.24ml
08Water（by KF Titration）4.0%-5.5%5.0%
09Relates substances （by HPLC;ph；Eur）a）For each of impurities A,B,C,D not more than 0.5%Impurities A,B,C,D; Not detected.
b）Among impurities A,B,C,D not more than one greater than 0.25%0
C）For each of unspecified impurities，not more than0.10%﹤0.05%
d）Total impurities not more than 1.0%﹤0.05%
10Residue on Ignition Not more than 1.0% 0.05%
11N，N-DimethylanilineNot more than 0.001%Conforms
12Phenolic compoundsNo blue-green color developsConforms
13Assay A （by HPLC）98.0%~102.0%（on anhydrous basis）100.0%
14Assay B（by titration）99.0%~101.0%（on anhydrous basis）100.4%
15Residual solvents Methanol≤3000ppm Toluene≤890ppm Acetone≤5000ppm 52ppm 0.8ppm 2ppm
16StoragePreserve in tight containers；protected from lightConforms
