Customization: | Available |
---|---|
Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
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Product Informations
Item |
Specifications |
Results |
Appearance |
A white crystalline powder |
white crystalline powder |
Identification |
A.The solution appears purple |
Conforms |
|
B.IR:consistent with the spectrum obtained with .Rimantadine Hydrochloride RS |
|
|
C.Specific Reaction of chloride |
|
PH |
4.5-6.5(1% solution in water) |
4.93 |
Clarity of solution |
Solution of substance must stand the comparison with etalon I |
Conforms |
Color of solution |
Color of solution must stand the comparison with etalon Y7 |
Conforms |
Sulphates |
NMT0.05% |
Conforms |
Toluene |
NMT890ppm |
Not detected |
Methanol |
NMT3000ppm |
Not detected |
Related substances (TLC) |
NMT1.0% |
Conforms |
Loss on drying |
NMT0.5% |
0.07% |
Sulphated ash |
NMT0.1% |
0.09% |
Ammonium |
NMT0.08% |
Conforms |
Heavy metals |
NMT0.001% |
Conforms |
Assay(On dry basis) |
99.0%-101.0% |
99.58% |
Solubility |
Freely Soluble in Chloroform and methanol, soluble in 95% ethanol an water. |
Conforms |
Microbiology |
Total bacterial count:<1000CFU/g |
30CFU/g |
|
Total Fungus count: <100CFU/g |
<10 CFU/g |
|
Escherichia coli:Not detected |
Not detected |
Conclusion |
The results conforms with Russian Registration Specification. |
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The group built up a long technology partnership with more than 100 institutes and universities at home and abroad meanwhile it enhances its own independent innovation system. Lunan Enterprise Technology center's technology innovative ability ranks the forefront in Pharmaceutical industry and got the title"Top Ten Best Industrial Enterprises of Domestic Pharmaceutical R & D Product Line".