Dorzolamide HCl 130693-82-2 USP 30
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Test items |
Specifications |
Results |
Appearance |
White to off-white crystalline powder |
Conforms |
Solubility |
Soluable in water |
Conforms |
Identification |
A. IR B. HPLC C. Test for Chloride |
Conforms |
Water |
No more than 0.5% |
0.22% |
Residue on ignition |
No more than 0.1% |
<0.1% |
Heavy metals |
No more than 0.001% |
<0.001% |
Limit of Dorzolamide hcl Related compound A |
No more than 0.5% |
0.36% |
Chromatographic purity |
Individual impurity: no more than 0.1% Total impurities: no more than 0.5% |
0.08% 0.25% |
Organic Volatile Impurities |
Acetone: no more than 5000ppm Acetonitrile: no more than 410ppm Ethyl Acetate: no more than 5000ppm Hexane: no more than 290ppm Methanol: no more than 3000ppm Tetrahydrofuran: no more than 720ppm Toluene: no more than 890ppm Isopropyl Alcohol: no more than 8000ppm |
<5000ppm <410ppm <5000ppm <290ppm <3000ppm <720ppm <890ppm <5000ppm |
Assay (on dried basis) |
99.0%~101.0%(C10H16N2O4S3·HCL) |
100.6% |
Conclusion: Conforms to the standard of USP30. |
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