test item |
analysis specification |
result |
description |
it occurs as white to yellowish white crystals or crystalline power |
white crystalline power |
solubility |
it is very soluble in water and in methanol, freely soluble in ethanol(95), and practically insoluble in diethyl ether |
meets |
optical rotation |
not show optical rotation |
meets |
identification a uv absorption b. ir absorption c. sodium salt |
a: compare the spectrums between the solution of loxoprofe sodium and crs, both spetra exhibit similar intensities of absorption at the same wavelengths. b: compare the infrared absorption spectrum of loxoprofe sodium with the reference spectrum; both spetra exhibit similar intensities of absorption at the same wavelengths. c: a solution of loxoprofe sodium (1~10) responds to the qualitative tests for sodium salt |
meets meets meets |
ph |
6.5~8.5 |
7.9 |
clarity and color of solution |
the solution is clear and colorless or pale yellow. the color is not darker than that of diluted matching fluid for color a(1 in 2) |
clear and colorless |
heavy metals |
≤10ppm |
<10ppm |
related substances |
the spots other than the principal spot from the sample solution are not intense than the spot from the standard solution. |
meets |
water |
11.0~13.0% |
12.0% |
assay(dry basis) |
≥98.5% |
99.5% |