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Benfotiamine
Product Name: Benserazide hydrochloride
Molecular Formula: C10H15N3O5·HCL
Molecular Weight: 293.7
CAS#: 14919-77-8
ITEMS
|
STANDARDS
|
Result
|
Identification:
|
IR
|
Complies
|
Opticalrotation
|
-0.05to+o.o5
|
+0.02
|
PH
|
4.0to 5.0
|
4.2
|
Impurity A
|
≤0.5%
|
0.02%
|
Individual other impurity
|
≤ 0.5%
|
0.30%
|
Total impurities :
|
≤1.0%
|
0.32%
|
Heavy metals:
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≤10ppm
|
Complies
|
Water
|
≤1.0%
|
0.4%
|
Sulfated ash
|
≤0.1%
|
0.070%
|
Assay on dry basis
|
98.5%— 101.5%
|
99.33%
|
CONCLUSION:ACCORD WITH EP7.0/BP2018
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|
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