Tolcapone
Product name (3,4-Dihydroxy-5-nitrophenyl)(4-methylphenyl)methanone
Structure
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Molecular Formula C14H11NO5
Molecular Weight 273.24
CAS Number 134308-13-7
NMPA approval No. H20050205
National Drug standards YBH02292005-2016Z
|
Test |
USP |
Results |
|
Color & Appearance |
yollow crystalline powder |
yollow crystalline powder |
|
Infrared spectrum |
consistent with the structure |
Conforms |
|
Assay (HPLC ) |
98.5 % ~101.5% |
99.9 % |
|
Total impurities (HPLC) |
NMT 0.5 % |
0. 1% |
|
Related compound A (4N-Methyl-3,4-dihydroxybenzophenone) |
NMT 0.1 % |
Conforms |
|
Related compound B (4-Hydroxy-3-methoxy-4¢-methyl-5-nitrobenzophenone ) |
NMT 0.2 % |
Conforms |
|
Unknown impurities ( individual ) |
NMT 0.1 % |
Conforms |
|
Loss on Drying |
NMT 0.1 % ( 80℃) |
0.06 % |
|
Residue on ignition |
NMT 0.1% |
0.05% |
|
Heavy metals (as Pb) |
NMT 20 ppm |
Conforms |
Package: 1kg
Storage ：Preserve in tight light-resistant containers ,and store between 20℃～25℃.