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Main efficacy and function of pharmaceutical grade triethanolamine Obtained
.
Calculated by anhydrous, the content of C6H15NO3 should be 99.
0%~103.
0%
.
【Properties】 This product is a colorless to slightly yellow viscous and clear liquid
.
This product is easily soluble in water or ethanol, and in dichloromethane Dissolved
.
Relative density The relative density of this product (general rule 0601) is 1.
120 to 1.
130
.
Refractive index The refractive index of this product (general rule 0622) is 1.
482 to 1.
485
.
[Identification] (1) Take 1ml of this product, add copper sulfate test solution 0.
3ml, it is blue
.
Add 2.
5ml of sodium hydroxide test solution, heat it to boiling, the blue color does not disappear
.
(2) Take 1ml of this product, add 0.
3ml of cobalt chloride test solution, it should be dark red
.
( 3) Take 1ml of this product and put it in a test tube, heat it slowly, the generated gas can make the wet red litmus paper turn blue
.
Dilute with water to the scale, shake well, and use it as the test solution; take another appropriate amount of triethanolamine reference substance, accurately weigh it, add water to dissolve and quantitatively dilute to make a solution containing about 0.
5mg per 1ml as the reference substance solution
.
For the chromatographic condition test under this item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution
.
【Check】 The clarity and color of the solution Take 12g of this product, put it in a 20ml measuring bottle, add water to dilute to the mark, and check according to the law (general rule 0901 and general rule 0902), the solution should be clear and colorless; Compared with the standard colorimetric solution (general rule 0901), it shall not be darker
.
Take about 10g of this product for related substances, accurately weigh it, put it in a 100ml measuring bottle, and accurately add the internal standard solution (take about 5g of 3-aminopropanol, put it in a 100ml measuring bottle, add water to dissolve and dilute to the mark, shake well) 1ml , add water to dissolve and dilute to the mark, shake well, and use it as the test solution; take another about 50mg of monoethanolamine reference substance, about 250mg of diethanolamine reference substance and about 50mg of triethanolamine reference substance, accurately weighed, put in a 10ml measuring bottle, Add water to dissolve and dilute to the mark, shake well, accurately measure 2ml, put it in a 100ml volumetric flask, accurately add 1ml of internal standard solution, dilute to the mark with water, shake well, and use it as a reference solution
.
According to the test of gas chromatography (General Rule 0521), a capillary column with 5% diphenyl-95% dimethyl siloxane as the stationary solution (or similar polarity) is used as the chromatographic column; The temperature was raised to 230°C at a rate of 30°C in minutes and maintained for 10 minutes; the inlet temperature was 260°C and the detector temperature was 290°C
.
The resolution between the monoethanolamine peak and the internal standard peak should be greater than 2.
0
.
Precisely measure 1 μl each of the test solution and the reference solution, inject them into a gas chromatograph, and record the chromatogram
.
Calculated by the peak area ratio according to the internal standard method, the ratio of the peak area of the monoethanolamine in the test solution to the peak area of the internal standard should not be greater than the ratio of the peak area of the monoethanolamine in the reference solution to the peak area of the internal standard (0.
1%), diethanolamine The ratio of peak area to internal standard peak area should not be greater than the ratio of diethanolamine peak area to internal standard peak area (0.
5%) in the reference solution, and the ratio of the sum of other impurity peak areas to the internal standard peak area should not be greater than that in the reference solution.
10 times (1.
0%) the ratio of the main peak area to the internal standard peak area
.
In the chromatogram of the test solution, any impurity peak smaller than 0.
5 times the area of the main peak of triethanolamine in the reference solution is ignored
.
Take about 1g of this product for moisture and measure it according to the moisture determination method (General Principle 0832 First Method 1), and the moisture content should not exceed 1.
0%
.
Take this product from the residue on ignition and inspect it according to the law (General Rule 0841), and the remaining residue shall not exceed 0.
1%
.
Take 1.
0g of this product for heavy metals, add 20ml of water to dissolve, and check according to the law (the first method of general rule 0821), and the heavy metal content should not exceed 10 parts per million
.
[Determination of content] Take about 1.
2g of this product, accurately weigh it, put it in a 250ml conical flask, add 75ml of freshly boiled and cooled water, add 0.
3ml of methyl red indicator solution, and titrate with hydrochloric acid titration solution (lmol/L).
To the solution microscopic red and keep for 30 seconds without fading
.
Each 1ml of hydrochloric acid titration solution (1mol/L) is equivalent to 149.
2mg of C6H15NO3
.
【Category】 Pharmaceutical excipients, emulsifiers and pH adjusters,
etc.
【Storage】 shading, sealed preservation
.
.
Calculated by anhydrous, the content of C6H15NO3 should be 99.
0%~103.
0%
.
【Properties】 This product is a colorless to slightly yellow viscous and clear liquid
.
This product is easily soluble in water or ethanol, and in dichloromethane Dissolved
.
Relative density The relative density of this product (general rule 0601) is 1.
120 to 1.
130
.
Refractive index The refractive index of this product (general rule 0622) is 1.
482 to 1.
485
.
[Identification] (1) Take 1ml of this product, add copper sulfate test solution 0.
3ml, it is blue
.
Add 2.
5ml of sodium hydroxide test solution, heat it to boiling, the blue color does not disappear
.
(2) Take 1ml of this product, add 0.
3ml of cobalt chloride test solution, it should be dark red
.
( 3) Take 1ml of this product and put it in a test tube, heat it slowly, the generated gas can make the wet red litmus paper turn blue
.
Dilute with water to the scale, shake well, and use it as the test solution; take another appropriate amount of triethanolamine reference substance, accurately weigh it, add water to dissolve and quantitatively dilute to make a solution containing about 0.
5mg per 1ml as the reference substance solution
.
For the chromatographic condition test under this item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution
.
【Check】 The clarity and color of the solution Take 12g of this product, put it in a 20ml measuring bottle, add water to dilute to the mark, and check according to the law (general rule 0901 and general rule 0902), the solution should be clear and colorless; Compared with the standard colorimetric solution (general rule 0901), it shall not be darker
.
Take about 10g of this product for related substances, accurately weigh it, put it in a 100ml measuring bottle, and accurately add the internal standard solution (take about 5g of 3-aminopropanol, put it in a 100ml measuring bottle, add water to dissolve and dilute to the mark, shake well) 1ml , add water to dissolve and dilute to the mark, shake well, and use it as the test solution; take another about 50mg of monoethanolamine reference substance, about 250mg of diethanolamine reference substance and about 50mg of triethanolamine reference substance, accurately weighed, put in a 10ml measuring bottle, Add water to dissolve and dilute to the mark, shake well, accurately measure 2ml, put it in a 100ml volumetric flask, accurately add 1ml of internal standard solution, dilute to the mark with water, shake well, and use it as a reference solution
.
According to the test of gas chromatography (General Rule 0521), a capillary column with 5% diphenyl-95% dimethyl siloxane as the stationary solution (or similar polarity) is used as the chromatographic column; The temperature was raised to 230°C at a rate of 30°C in minutes and maintained for 10 minutes; the inlet temperature was 260°C and the detector temperature was 290°C
.
The resolution between the monoethanolamine peak and the internal standard peak should be greater than 2.
0
.
Precisely measure 1 μl each of the test solution and the reference solution, inject them into a gas chromatograph, and record the chromatogram
.
Calculated by the peak area ratio according to the internal standard method, the ratio of the peak area of the monoethanolamine in the test solution to the peak area of the internal standard should not be greater than the ratio of the peak area of the monoethanolamine in the reference solution to the peak area of the internal standard (0.
1%), diethanolamine The ratio of peak area to internal standard peak area should not be greater than the ratio of diethanolamine peak area to internal standard peak area (0.
5%) in the reference solution, and the ratio of the sum of other impurity peak areas to the internal standard peak area should not be greater than that in the reference solution.
10 times (1.
0%) the ratio of the main peak area to the internal standard peak area
.
In the chromatogram of the test solution, any impurity peak smaller than 0.
5 times the area of the main peak of triethanolamine in the reference solution is ignored
.
Take about 1g of this product for moisture and measure it according to the moisture determination method (General Principle 0832 First Method 1), and the moisture content should not exceed 1.
0%
.
Take this product from the residue on ignition and inspect it according to the law (General Rule 0841), and the remaining residue shall not exceed 0.
1%
.
Take 1.
0g of this product for heavy metals, add 20ml of water to dissolve, and check according to the law (the first method of general rule 0821), and the heavy metal content should not exceed 10 parts per million
.
[Determination of content] Take about 1.
2g of this product, accurately weigh it, put it in a 250ml conical flask, add 75ml of freshly boiled and cooled water, add 0.
3ml of methyl red indicator solution, and titrate with hydrochloric acid titration solution (lmol/L).
To the solution microscopic red and keep for 30 seconds without fading
.
Each 1ml of hydrochloric acid titration solution (1mol/L) is equivalent to 149.
2mg of C6H15NO3
.
【Category】 Pharmaceutical excipients, emulsifiers and pH adjusters,
etc.
【Storage】 shading, sealed preservation
.