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items |
standard |
test result |
appearance |
white or almost white crystalline powder |
white crystalline powder |
identification |
||
a. infrared absorption |
the infrared absorption spectrum is concordant with the reference spectrum |
conform |
b. ultraviolet absorption |
absorptivities at 272nm, calculated on the dried base, do not differ by more than 3% |
1% |
specific rotation |
-17.0°~-15.3° |
-16.8° |
loss on drying |
≤1.0% |
0.2% |
heavy metals |
≤0.002% |
<0.002% |
free naproxen |
≤1.0% |
0.1% |
related substances(hplc) |
||
impurity d(in-house) |
≤0.10% |
<0.01% |
impurity e(in-house, impurity c in ep) |
≤0.10% |
<0.01% |
any other impurity |
≤0.10% |
<0.01% |
total impurities |
≤0.5% |
<0.01% |
residual solvents |
||
toluene |
≤50ppm |
<1ppm |
methanol |
≤50ppm |
<4ppm |
assay(on dry basis) |
98.5%~101.5% |
100.4% |
conclusion |
the results conform with usp38. |
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