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Pharmaceutical grade magnesium stearate experimental declaration research and development test 1.
Sodium hydroxide titration solution (0.
1mol/L) preparation: take a clear sodium hydroxide saturated solution of 5.
6mL, add new boiled cold water to make 1000mL
.
Calibration: take at 105 °C dryed to a constant weight of the reference potassium phthalate of about 0.
6g, precision weighing, add new boiled cold water 50mL, shake, so that it is as dissolved as possible; add 2 drops of phenolphthalein indicator solution, titration with this solution, near the end point, should be made potassium phthalate completely dissolved, titrated until the solution appears pink
.
Each 1 mL sodium hydroxide titration solution (0.
1 mol/L) is equivalent to 20.
42 mg of potassium bicarboxylate
.
According to the consumption of this solution and the amount of potassium hydrogen phthalate, the concentration
of this solution is calculated.
Storage: placed in polyethylene plastic bottle, sealed and stored; There are 2 holes in the plug, 1 glass tube is inserted into each hole, 1 tube is connected to the sodium lime tube, and 1 tube is used for aspirating
the solution.
2.
Sulfuric acid titration solution (0.
05mol/L) preparation: take 3mL of sulfuric acid, slowly inject the appropriate amount of water, cool to room temperature, add water to dilute to 1000mL, shake well
.
Calibration: take at 270-300 °C dry constant weight of the reference anhydrous sodium carbonate about 0.
15g, precision weighing, add water 50mL to dissolve, add methyl red - bromocresol green mixed indicator solution 10 drops, titration with this solution to change from green to purple red, boil for 2 minutes, cool to room temperature, continue to titrate until the color of the solution has green to dark purple
.
Each 1 mL sulfuric acid titration solution (0.
05 mol/L) is equivalent to 5.
30 mg of anhydrous sodium
carbonate.
According to the consumption of this liquid and the amount of anhydrous sodium carbonate, calculate the concentration of this solution, that is, obtained
.
Operation steps: take about 1.
0g of this product, precision weighing, precision sulfate solution (0.
05mol/L) 50mL, boil until the oil layer is clear, continue to heat for 10 minutes, let cool, add 12 drops of methyl orange indicator solution, titrate with sodium hydroxide titration solution (0.
1mol/L), each 1mL sulfuric acid titration solution (0.
05mol/L) is equivalent to 2.
016mg mgO
.