Dextromethorphan Hydrobromide Monohydrate DXM DMHM Dextromethorphan HBR

Dextromethorphan Hydrobromide Monohydrate Dxm Dmhm Dextromethorphan Hbr

Dextromethorphan Hydrobromide Monohydrate DXM DMHM Dextromethorphan HBR

Dextromethorphan HBR
Product Name: Dextromethorphan hydrobromide monohydrate
Other Names:DXM; DMHM; D-3-METHOXY-N-METHYLMORPHINAN HYDROBROMIDE;DEXTROMETHORPHAN HYDROBROMIDE
CAS:    6700-34-1
MF:    C18H28BrNO2
MW:    370.32
Melting point:    116-119°C
Chemical Properties: White crystalline powder

DXM Dextromethorphan HBR Uses: An antitussive drug. Orally active synthetic morphine analog. Analgesic (narcotic). Racemethorphan and levomethorpham are controlled substances (opiates). Biological Activity    Non-competitive, low affinity NMDA receptor antagonist. Antitussive, anticonvulsive and neuroprotective agent.

DXM Dextromethorphan HBR raws powder Chemical Test Specifications (COA):

Product name
Dextromethorphan Hydrobromide
CAS
CAS No.
6700-34-1
Outer Packing
25KG
25KG /drum
Production date
2017.06.11
Shelf life
2020.06.10
Standard adopted
USP38/EP8
USP38/EP8
Items of analysis
Specification
Results
Apperance
Practically white crystal or crystalline powder
White crystalline powder
FT-IR
The sample spectrum correspond to that of the reference standard
Conforms
UV
≤3.0%,
Not more than 3.0% difference of RS(on anhydrous basis)
2.7%
2.7%
Bromide Test
Yellow white precipitate forme
Conforms
A
Specific rotation A
1.8w/v 25ºC325nm≤1.0%,
1.8w/v in water:Not more than 1.0%difference of RS
0.4%
0.4%
B
Specific rotation B
2.0%w/v(0.1M)20ºC589nm+28ºC+30ºC,
2.0%w/v in 0.1M HCL: +28ºCto +30ºC at 589nm and 20ºC(on anhydrous basis)
+28.4ºC
+28.4ºC
Clarity of solution
5.0%w/v
5.0%w/v in alcohol:Clear and colorless
Conforms
PH
PH
5.2-6.5
5.2-6.5(1 in 100 water solution)
5.7
5.7
Acidity or Alkalinity
0.01M≤0.4ml
Not more than 0.4ml of 0.01M HCLconsumed
0.30ml
0.30ml
Water(by KF Titration)
4.0%-5.5%
4.0%-5.5%
4.9%
4.9%
A,B,C,D
impurities A,B,C,D
A,B,C,D≤0.5%
For each of impurities A,B,C,D not more than 0.5%
A,B,C,D;
Impurities A,B,C,D; Not detected.
A,B,C,D
impurities A,B,C,D
A,B,C,D0.25%≤1
Among impurities A,B,C,D not more than one greater than 0.25%
0
0
For each of unspecified impurities
≤0.1.%
not more than0.10%
<0.05%
<0.05%
Total impurities
≤1.0%
not more than 1.0%
<0.05%
<0.05%
Residue on Ignition
0.1%
Not more than 0.1%
0.08%
0.08%
N.N
N,N-Dimethylaniline
0.001%
Not more than 0.001%
Conforms
Phenolic compounds
No blue-green color develops
Conforms
A-HPLC
Assay A (by HPLC)
98.0%~102.0%,
98.0%~102.0%(on anhydrous basis)
99.9%
99.9%
B-
Assay B(by titration)
99.0%~101.0%,
99.0%~101.0%(on anhydrous basis)
99.2%
99.2%
Methanol
≤3000ppm
≤3000ppm
N.D
Toluene
≤890ppm
≤890ppm
5.8ppm
5.8ppm
Acetone
≤5000ppm
≤5000ppm
Conforms
Conforms
Storage
,
Preserve in tight containers;protected from light
Conforms
Conclusion
Qualified

 

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