Pharmaceutical grade chlorhexidine gluconate solution content 20 chlorhexidine

The content of pharmaceutical grade chlorhexidine gluconate solution is 20 chlorhexidine [check] The acidity is taken as a 5% (ml/m1) aqueous solution of this product, and determined according to the law (general rule 0631), and the pH value should be 5.
5 to 7.
0
.

For p-chloroaniline, take 2.
0ml of this product, dilute it with water to 50ml, take 5ml, add 10ml of hydrochloric acid solution (9→100) and 20ml of water, then add 1ml of 0.
5mol/L sodium nitrite solution and 2ml of 5% ammonium sulfamate solution in turn , shake well, let stand for 5 minutes, add 5 ml of 0.
1% naphthylethylenediamine dihydrochloride solution and 1 ml of ethanol, add an appropriate amount of water to dilute to 50 ml, shake well, and leave for 30 minutes.
Appropriate amount of chloroaniline, accurately weighed, dissolved in hydrochloric acid solution (9→100) and quantitatively diluted to make a solution containing about 10 μg per 1 ml] 10.
0 ml of the control solution prepared by the same method should not be deeper (0.
25%)
.

Relevant substances are tested according to thin-layer chromatography (General Rule 0502)
.

For the test solution, take an appropriate amount of this product, add 1.
5mol/L acetic acid solution to dissolve and dilute to make a solution containing about 6mg per 1ml
.

　　Control solution (1) Precisely measure an appropriate amount of the test solution, quantitatively dilute it with 1.
5mol/L acetic acid solution to prepare a solution containing about 30μg per 1ml
.

　　Control solution (2) Precisely measure an appropriate amount of the test solution, and quantitatively dilute it with 1.
5mol/L acetic acid solution to prepare a solution containing about 120μg per 1ml
.

　　Chromatographic conditions use silica gel GF254 thin-layer plate (take silica gel GF2548g, add 24ml of water containing 1g of sodium formate), and use absolute ethanol-formic acid (60:30:9) as the developing solvent
.

　　The assay method draws 5 μl of each of the above three solutions, points them on the same thin-layer plate, unfolds, takes them out, air-dries them, and inspects them under an ultraviolet lamp (254 nm)
.

　　If there are impurity spots in the limit test solution, its color should not be darker than that of the main spot of the control solution (1)
.

　　Residues on ignition shall not exceed 0.
1% (General Rule 0841)
.

　　【Determination of content】 Determined by UV-Vis spectrophotometry (General Rule 0401)
.

　　Take about 1g of the test solution, accurately weigh it, put it in a 200ml measuring bottle, add water to dissolve and dilute to the mark, shake well, accurately measure 2ml, put it in a 200ml measuring bottle, add 10.
6ml of ethanol, and then use 80% Dilute the ethanol solution to volume and shake well
.

　　Determination method Take the test solution, measure the absorbance at the wavelength of 259nm, and calculate according to the absorption coefficient ( ) of C22H30Cl2N10·2C6H12O7 is 413
.

　　【Category】 Disinfectant and antiseptic
.