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Pharmaceutical grade sodium starch glycolate 25kg is shipped with the Pharmacopoeia standard.
[Check] pH Take 1.
0g of this product, add 100ml of water, shake and disperse, and then measure it according to law (General Rule 0631), which should meet the requirements of the attached table
.
Sodium Chloride Take about 0.
5g of this product, accurately weigh it, put it in a 250ml conical flask, add 150ml of water, shake well, add 1ml of potassium chromate indicator solution, and titrate with silver nitrate titration solution (0.
1mol/L)
.
Each 1ml of silver nitrate titration solution (0.
1mol/L) is equivalent to 5.
844mg of NaCl
.
Calculated according to the dry product, it should meet the requirements of the attached table
.
Sodium Glycolate Protect from light
.
Take 0.
2g of this product, accurately weigh it, put it in a beaker, add 5ml of 5mol/L acetic acid solution and 5ml of water, and stir for about 15 minutes until the sodium glycolate dissolves; add 50ml of acetone and 1g of sodium chloride, and stir to make the carboxymethyl starch completely Precipitate, filter, put the filtrate in a 100ml volumetric flask, add acetone to dilute to the mark, shake well; let stand for 24 hours, and take the supernatant as the test solution
.
Take 0.
310g of glycolic acid dried under reduced pressure at room temperature for 12 hours, accurately weigh it, put it in a 500ml measuring bottle, add water to dissolve and dilute to the mark, shake well, accurately measure 5ml, put it in a 100ml measuring bottle, add 5mol/L acetic acid solution 5ml, let stand for 30 minutes, add 80ml of acetone and 1g of sodium chloride, shake well, add acetone to dilute to the mark, shake well, and let stand for 24 hours as a control solution
.
Take 2.
0ml each of the test solution and the control solution, put them in 25ml Nessler colorimetric tubes respectively, heat in a water bath until the acetone evaporates, let it cool, add 2,7-dihydroxynaphthalene sulfuric acid solution (take 2,7-dihydroxynaphthalene) 10mg of naphthalene, dissolved in 100ml of sulfuric acid, placed until the color fades, use within 2 days) 20ml, tightly plug, shake well, heat in a water bath for 20 minutes, and cool
.
Compared with the control solution, the color of the test solution should not be darker
.
If necessary, take the above two solutions, according to UV-Vis spectrophotometry (general rule 0401), within 10 minutes, measure the absorbance at a wavelength of 540nm, and calculate that the sodium glycolate content should not exceed 2.
0%
.
Take about 0.
5g of this product, accurately weigh it, put it in a 50ml centrifuge tube, add an appropriate amount of water, shake for about 1 minute, centrifuge, quantitatively transfer the supernatant to a 25ml volumetric flask, and extract the residue twice with water in the same way, and combine them.
The supernatant is placed in the same 25ml measuring bottle, diluted with water to the mark, shaken well, filtered, and the subsequent filtrate is taken as the test solution; about 50mg of the reference substance is taken, accurately weighed, placed in a 50ml measuring bottle, and diluted with water to the mark , Precisely measure an appropriate amount, dilute with water to make a solution containing 40μg per 1ml, as a reference solution
.
Take an appropriate amount of sodium chloride, dissolve and dilute with water to make a mixed solution containing 2μg per 1ml, as a system suitability solution
.
According to the test of ion chromatography (general rule 0513), an anion exchange chromatography column (or a chromatography column with equivalent performance) using alkanol quaternary ammonium as the functional group of ethylvinylbenzene-divinylbenzene polymer resin as filler; 30 ℃; the eluent is 10 mmol/L potassium hydroxide solution, the flow rate is 1.
0 ml per minute; the suppression type conductivity detector, the temperature of the detection cell is 35 ℃
.
Precisely measure 25 μl of the system suitability solution, inject it into the ion chromatograph, and record the chromatogram.
The resolution of the peak and the chloride ion peak should meet the requirements
.
Precisely measure 25 μl of the test solution and the reference solution, respectively, inject them into the ion chromatograph, and calculate the peak area according to the external standard method, and the content should not exceed 0.
2%
.
[Check] pH Take 1.
0g of this product, add 100ml of water, shake and disperse, and then measure it according to law (General Rule 0631), which should meet the requirements of the attached table
.
Sodium Chloride Take about 0.
5g of this product, accurately weigh it, put it in a 250ml conical flask, add 150ml of water, shake well, add 1ml of potassium chromate indicator solution, and titrate with silver nitrate titration solution (0.
1mol/L)
.
Each 1ml of silver nitrate titration solution (0.
1mol/L) is equivalent to 5.
844mg of NaCl
.
Calculated according to the dry product, it should meet the requirements of the attached table
.
Sodium Glycolate Protect from light
.
Take 0.
2g of this product, accurately weigh it, put it in a beaker, add 5ml of 5mol/L acetic acid solution and 5ml of water, and stir for about 15 minutes until the sodium glycolate dissolves; add 50ml of acetone and 1g of sodium chloride, and stir to make the carboxymethyl starch completely Precipitate, filter, put the filtrate in a 100ml volumetric flask, add acetone to dilute to the mark, shake well; let stand for 24 hours, and take the supernatant as the test solution
.
Take 0.
310g of glycolic acid dried under reduced pressure at room temperature for 12 hours, accurately weigh it, put it in a 500ml measuring bottle, add water to dissolve and dilute to the mark, shake well, accurately measure 5ml, put it in a 100ml measuring bottle, add 5mol/L acetic acid solution 5ml, let stand for 30 minutes, add 80ml of acetone and 1g of sodium chloride, shake well, add acetone to dilute to the mark, shake well, and let stand for 24 hours as a control solution
.
Take 2.
0ml each of the test solution and the control solution, put them in 25ml Nessler colorimetric tubes respectively, heat in a water bath until the acetone evaporates, let it cool, add 2,7-dihydroxynaphthalene sulfuric acid solution (take 2,7-dihydroxynaphthalene) 10mg of naphthalene, dissolved in 100ml of sulfuric acid, placed until the color fades, use within 2 days) 20ml, tightly plug, shake well, heat in a water bath for 20 minutes, and cool
.
Compared with the control solution, the color of the test solution should not be darker
.
If necessary, take the above two solutions, according to UV-Vis spectrophotometry (general rule 0401), within 10 minutes, measure the absorbance at a wavelength of 540nm, and calculate that the sodium glycolate content should not exceed 2.
0%
.
Take about 0.
5g of this product, accurately weigh it, put it in a 50ml centrifuge tube, add an appropriate amount of water, shake for about 1 minute, centrifuge, quantitatively transfer the supernatant to a 25ml volumetric flask, and extract the residue twice with water in the same way, and combine them.
The supernatant is placed in the same 25ml measuring bottle, diluted with water to the mark, shaken well, filtered, and the subsequent filtrate is taken as the test solution; about 50mg of the reference substance is taken, accurately weighed, placed in a 50ml measuring bottle, and diluted with water to the mark , Precisely measure an appropriate amount, dilute with water to make a solution containing 40μg per 1ml, as a reference solution
.
Take an appropriate amount of sodium chloride, dissolve and dilute with water to make a mixed solution containing 2μg per 1ml, as a system suitability solution
.
According to the test of ion chromatography (general rule 0513), an anion exchange chromatography column (or a chromatography column with equivalent performance) using alkanol quaternary ammonium as the functional group of ethylvinylbenzene-divinylbenzene polymer resin as filler; 30 ℃; the eluent is 10 mmol/L potassium hydroxide solution, the flow rate is 1.
0 ml per minute; the suppression type conductivity detector, the temperature of the detection cell is 35 ℃
.
Precisely measure 25 μl of the system suitability solution, inject it into the ion chromatograph, and record the chromatogram.
The resolution of the peak and the chloride ion peak should meet the requirements
.
Precisely measure 25 μl of the test solution and the reference solution, respectively, inject them into the ion chromatograph, and calculate the peak area according to the external standard method, and the content should not exceed 0.
2%
.
