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Pharmaceutical Grade Chlorhexidine Gluconate 25kg Pharmacopoeia Standard [Check] Take the 5% (ml/m1) aqueous solution of this product for acidity and measure it according to the law (General Rule 0631.
The pH value should be 5 to 0.For p-chloroaniline, take 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 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 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 minute.
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 ml of the control solution prepared by the same method should not be deeper (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 5mol/L acetic acid solution to dissolve and dilute to make a solution containing about 6mg per 1m.
Control solution (1) Precisely measure an appropriate amount of the test solution, quantitatively dilute it with 5mol/L acetic acid solution to prepare a solution containing about 30μg per 1m.
Control solution (2) Precisely measure an appropriate amount of the test solution, and quantitatively dilute it with 5mol/L acetic acid solution to prepare a solution containing about 120μg per 1m.
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 solven.
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 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 16ml of ethanol, and then use 80% Dilute the ethanol solution to volume and shake wel.
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.
The pH value should be 5 to 0.For p-chloroaniline, take 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 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 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 minute.
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 ml of the control solution prepared by the same method should not be deeper (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 5mol/L acetic acid solution to dissolve and dilute to make a solution containing about 6mg per 1m.
Control solution (1) Precisely measure an appropriate amount of the test solution, quantitatively dilute it with 5mol/L acetic acid solution to prepare a solution containing about 30μg per 1m.
Control solution (2) Precisely measure an appropriate amount of the test solution, and quantitatively dilute it with 5mol/L acetic acid solution to prepare a solution containing about 120μg per 1m.
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 solven.
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 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 16ml of ethanol, and then use 80% Dilute the ethanol solution to volume and shake wel.
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.
