Medicinal grade chlorhexidine gluconate solution Chlorhexidine content 20 pharmacopeia standard

Medicinal grade chlorhexidine gluconate solution Chlorhexidine content 20 pharmacopoeia standard [check] acidity Take 5% (ml/m1) of this product, measured according to law (general 0631), pH should be 5.
5 ~ 7.
0
.

P-Chloroaniline Take 2.
0ml of this product, dilute with water to 50ml, take 5ml, add hydrochloric acid solution (9→100) 10ml and water 20ml, add 0.
5mol/L sodium nitrite solution 1ml and 5% ammonium sulfonate solution 2ml, shake well, let it sit for 5 minutes, add 0.
1% naphthylene hydrochloride ethylenediamine solution 5ml and ethanol 1ml, then add water to dilute to 50ml, shake well, leave for 30 minutes, such as color, Compared with the p-chloroaniline solution [take an appropriate amount of p-chloroaniline, precisely weigh, add hydrochloric acid solution (9→100) dissolved and quantitatively diluted to make a solution containing about 10 μg per 1 ml] 10.
0 ml of control solution made by the same method, not deeper (0.
25%)
.

Related substances according to thin layer chromatography (General Principle 0502) test
.

Sample 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) Take an appropriate amount of the test solution in a precise amount, and quantitatively dilute it with 1.
5mol/L acetic acid solution to make a solution
containing about 30 μg per 1 ml.

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

Chromatographic conditions Using silica gel GF254 thin layer plate (take silica gel GF2548g, add 1 g of sodium formate containing 24ml of water), with - anhydrous ethanol - formic acid (60:30:9) as the unfolding agent
.

Assay Aspirate 5 μl of each of the above three solutions, point to the same thin layer plate, unfold, remove, dry, and place under a UV lamp (254 nm) for inspection
.

Limits If the test solution shows impurity spots, its color should not be deeper than the main spots of the control solution (1), and if there are 1 to 2 impurity spots exceeding, it should not be deeper than the main spots
of the control solution (2).

The residue of the burning shall not exceed 0.
1% (General 0841).
【Content determination】 Measured by ultraviolet-visible spectrophotometry (General Rule 0401
).

Sample solution Take about 1g of this product, weigh it precisely, put it in a 200ml measuring bottle, add water to dissolve and dilute to the scale, shake well, take a precision amount of 2ml, put it in a 200ml measuring bottle, add ethanol 10.
6ml, and then dilute it with 80% ethanol solution to the scale, shake well
.

The assay method takes the solution for the test, determines the absorbance at a wavelength of 259 nm, and calculates
the absorption coefficient () of C22H30Cl2N10·2C6H12O7 as 413.