Estrogen based substances
Three female mice weighing 18 ~ 20g were selected and their ovaries were
removed. 2 to 3 weeks later, subcutaneous injection containing 1250 units of
sodium chloride injection per lml was given 4 times, 0.2ml each time, once in
the afternoon of the first day, once in the afternoon of the second day, once in
the afternoon of the third day and once in the morning of the third day. On the
morning of the fourth, fifth and sixth day, the vagina of each mouse was washed
with a small amount of sodium chloride injection to make vaginal smears, which
were observed under a low-power microscope and did not show positive reaction
(positive reaction refers to the majority of keratinocytes or epithelial cells
in the smears).
Residual solvent
Take this product 0.lg, precision weighing, put it in the top empty bottle,
precision add 2ml water to dissolve, seal, as the test product solution; Take an
appropriate amount of anhydrous ethanol, weigh it accurately, and dilute it
quantitatively with water to make a solution containing 0.25mg per lml. Take a
precise amount of 2ml, put it in a top-empty bottle, seal it, and use it as a
reference solution. According to the residual solvent determination method
(general 0861 second method), with polyethylene glycol as the fixed solution;
The initial temperature was 60°C for 5 minutes, and the temperature was heated
up to 200°C at a rate of 50°C per minute for 15 minutes. The inlet temperature
was 200°C; The temperature of the detector is 250°C. The equilibrium temperature
of the headspace bottle is 90°C and the equilibrium time is 20 minutes. The
control solution and test solution were respectively injected into the
headspace, and the chromatograms were recorded. The residual amount of ethanol
should conform to the regulations according to the peak area calculation by
external standard method.
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