The amount of pharmaceutical grade propylene glycol 500 grams of preparation has been recorded

Pharmaceutical grade propylene glycol 500 grams of preparation dosage has been recorded [check] acidity Take 10.
0ml of this product, add new boiling and put cold water 50ml to dissolve, add 3 drops of bromothymol phenol blue indicator solution, titrate with sodium hydroxide titration solution (0.
01mol/L) until the solution appears blue, and consume the volume of sodium hydroxide titration solution (0.
01mol/L) shall not exceed 0.
5ml
.
Chloride Take 1.
0ml of this product, check according to law (General Rule 0801), and compare with the control solution made of standard sodium chloride solution 7.
0ml, it shall not be more concentrated (0.
007%)
.
Sulfate Take 5.
0ml of this product, check according to law (General 0802), and compare with the control solution made of 3.
0ml of standard potassium sulfate solution, it shall not be more concentrated (0.
006%)
。 Relevant substances take an appropriate amount of this product, precise weighing, with anhydrous ethanol quantitative dilution to make a solution containing about 0.
5g per 1ml, as a test solution; another diethylene glycol (diethylene glycol), a dipropylene glycol, dipropylene glycol and propylene oxide control, precision weighing, dilution with absolute ethanol to make each 1ml containing 5μg, 500μg, 150μg and 5μg of mixed solution, as a control solution
。 According to gas chromatography (General Rule 0521) test, the capillary column with polyethylene glycol 20M (or similar polarity) as the fixed liquid is the column, the starting temperature is 80 °C, maintained for 3 minutes, and the temperature is heated to 220 °C at a rate of 15 °C per minute for 4 minutes; The inlet temperature is 230°C; The detector temperature is 250°C
.
The resolution of the peaks of each component should meet the requirements
.
Precise quantity of the test solution and the control solution are each 1 μl, respectively, injected into the gas chromatograph, according to the external standard method to calculate
the peak area.
Containing one diethyl glycol (diethylene glycol) shall not exceed 0.
001%, one dipropylene glycol shall not exceed 0.
1%, three propylene glycol shall not exceed 0.
03%, and propylene oxide shall not exceed 0.
001%.

。 Oxidizing substances Take 5.
0ml of this product, put iodine in a dosage bottle, add potassium iodide test solution 1.
5ml with dilute sulfuric acid 2ml, dense plug, place in a dark place for 15 minutes, add starch indicator solution 2ml, if blue, titrate with sodium thiosulfate titration solution (0.
005mol / L) to blue disappear, and the titration results are corrected with blank tests, and the volume of sodium thiosulfate titration solution (0.
005mol/L) consumed shall not exceed 0.
2ml
。 Reducing substance Take 1.
0ml of this product, add 1ml of ammonia test solution, heat in a 60 °C water bath for 5 minutes, the solution should not appear yellow; quickly add silver nitrate test solution 0.
15ml, shake well, place for 5 minutes, the solution should be unchanged
.
Moisture Take this product, according to the moisture determination method (general rule 0832 first method 1) to measure, the moisture content shall not exceed 0.
2%.

Blazing residue Take 50g of this product, heat to combustion, that is, stop heating, so that natural combustion to dry, at 700 ~ 800 ° C blazing to constant weight, the residual residue shall not exceed 2.
5mg
.
Heavy metals Take 4.
0ml of this product, add 19ml of water and acetate buffer (pH 3.
5) 2ml, check according to law (General 0821 First Law), containing heavy metals shall not exceed 5
parts per million.
Arsenic salt Take 1.
0g of this product, add 5ml of hydrochloric acid and 23ml of water, check according to law (General 0822), should comply with the provisions (0.
0002%)
.