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