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Nom du produit
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Dextromethorphan Hydrobromide
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CAS
n ° CAS.
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6700-34-1
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Emballage extérieur
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25KG
25KG /drum
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|
Date de production
|
2017.06.11
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Durée de conservation
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2020.06.10
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|
Norme adoptée
|
USP38/EP8
USP38/EP8
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Éléments d'analyse
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spécification
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Résultats
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Apparence
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Practically white crystal or crystalline powder
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Poudre cristalline blanche
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|
FT-IR
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The sample spectrum correspond to that of the reference standard
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Conforme
|
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UV
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≤3.0%,
Not more than 3.0% difference of RS(on anhydrous basis)
|
2.7%
2.7%
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|
Bromide Test
|
Yellow white precipitate forme
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Conforme
|
|
UN
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
|
Conforme
|
|
PH
PH
|
5.2-6.5
5.2-6.5(1 dans 100 water solution)
|
5.7
5.7
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|
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%
|
|
UN,B,C,D
impurities A,B,C,D
|
UN,B,C,D≤0.5%
For each of impurities A,B,C,D not more than 0.5%
|
UN,B,C,D;
Impurities A,B,C,D; Not detected.
|
|
UN,B,C,D
impurities A,B,C,D
|
UN,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%
|
Conforme
|
|
Phenolic compounds
|
No blue-green color develops
|
Conforme
|
|
A-HPLC
Assay A (par 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
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N.D
|
|
Toluene
|
≤890ppm
≤890ppm
|
5.8ppm
5.8ppm
|
|
Acetone
|
≤5000ppm
≤5000ppm
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Conforme
Conforme
|
|
Espace de rangement
|
,
Preserve in tight containers;protected from light
|
Conforme
|
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Conclusion
|
Qualifié
|
