Description
INTRODUCTION:
Naftopidil (INN, marketed under the brand name Flivas), an antihypertensive medicine, is used as a selective α1-adrenergic receptor antagonist or α-blocker.
FUNCTION:
Naftopidil (INN, marketed under the brand name Flivas), an antihypertensive medicine, is used as a selective α1-adrenergic receptor antagonist or α-blocker.
FUNCTION:
For voiding dysfunction caused by benign prostatic hyperplasia.
Product name | Naftopidil | |
Quality standard | Quality Standard | |
TESTS | SPECIFICATIONS | RESULTS |
Characteristics | White or almost white crystalline powder | almost white crystalline powder |
Melting point | 125~128℃ | 127~128℃ |
Identification | 1.IR | Conforms |
2.HPLC | Conforms | |
Loss on drying | ≤1.0% | 0.10% |
Residue on ignition | ≤ 0.1% | 0.04% |
Heavy metals | ≤20PPM | <20PPM |
Related substances | ≤1.0% | 0.24% |
N,N-DMF | ≤0.06% | 0.00% |
Microbial Limit bacteria | ||
total plate count | ≤1000个/g | Conforms |
yeast & mold | ≤100个/g | Conforms |
Assay |
C24H28N2O3≥99.0% not less than 99.0% percent of C24H28N2O3 dried basis |
99.20% |
Conclusion: Conform to Interior Quality standard. |