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CAS NO.16051-77-7
1.Product description
Product Name: Isosorbide 5-mononitrate
CAS: 16051-77-7
MF: C6H9NO6
MW: 191.14
EINECS: 240-197-2
2.Physical properties
mp 88-93 °C
alpha 170 º (c=1, EtOH)
refractive index 145 ° (C=5, H2O)
storage temp. -20°C Freezer
Water Solubility soluble
3.Specification
Items |
Specifications |
Results |
Description |
A white powder |
White powder |
Identification |
a) IR: consistent with the spectrum obtained with that of its RS. b) HPLC: the retention time of the principle peak corresponds to that of its RS. c) TCL for lactose: position, color and size to the principal spot is consistent with that obtained with reference solution |
Conforms
Conforms
Conforms |
Nitrates |
NMT 0.5% |
Conforms |
Heavy metals |
NMT 10ppm |
Conforms |
Related substances |
Isosorbide: NMT 0.20% Isosorbide 2-nitrate: NMT 0.25% Isosorbide dinitrate: NMT 0.25% Any other single impurity (major): NMT 0.1% Total impurities: NMT 0.5% |
Conforms 0.023% 0.041% 0.0026% 0.067% |
Microbiological Quality |
Total aerobic microbial count: NMT 900cfu/g Total combined yeasts/Molds count: NMT 90 cfu/g Escherichia. Coli: absence |
<10cfu/g <10cfu/g absence |
Assay (Isosorbide Mononitrate) |
66.5%~73.5% |
68.5% |
Conclusion: conforms to the requirement of USP32 standard. |
4.Application
A metabolite of Isosorbide Dinitrate. Used as an antianginal.
antidepressant, 5HT reuptake inhibitor
5.Packing
25KG/Drum or as per your requirement
6.Service we can provide: