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Pharmaceutical grade sodium methyl paraben cas5026-62-0 Usage Chinese alias: methyl paraben; sodium methyl paraben; CAS no: [5026-62-0] Molecular formula: C8H7NaO3 Structural formula: see relative molecular mass : 174.
12 Appearance: White or off-white crystalline powder
.
Solubility: easily soluble in water, slightly soluble in ethanol, almost insoluble in dichloromethane
.
[Check] Alkalinity Take 0.
10g of this product, dissolve it in 100ml of water, and measure it according to the law (General Rule 0631).
The pH value should be 9.
5~10.
5
.
For the clarity and color of the solution, take 1.
0g of this product, add 10ml of water to dissolve it, and check it according to the law (General Rule 0902), the solution should be clear; No deeper
.
For chloride, take 2.
0g of this product, add 40ml of water to dissolve, adjust the solution to neutrality with dilute nitric acid, dilute to 50ml with water, shake, filter, take 5.
0ml of the filtrate, check according to the law (General Rule 0801), and compare with standard chlorination Compared with the control solution made of 7.
0ml of sodium solution, it should not be more concentrated (0.
035%)
.
Sulfate Take 25ml of the subsequent filtrate under the chloride item and check according to the law (General Rule 0802).
Compared with the control solution made of 2.
4ml of standard potassium sulfate solution, it should not be more concentrated (0.
024%)
.
Take an appropriate amount of this product for related substances, dissolve and dilute it with mobile phase to make a solution containing 1.
0 mg per 1 ml, as the test solution; accurately measure an appropriate amount, dilute with mobile phase to prepare a solution containing 10 μg per 1 ml, as control solution
.
According to the chromatographic conditions under the content determination item, take 20 μl of the control solution and inject it into the liquid chromatograph, record the chromatogram, the signal-to-noise ratio of the main component peak height should be greater than 10; then precisely measure 20 μl of the test solution and the control solution, respectively.
Inject into the liquid chromatograph, record the chromatogram to 4 times the retention time of the main component peak
.
If there is a peak consistent with the retention time of the p-hydroxybenzoic acid peak in the chromatogram of the test solution, its peak area should not be greater than 3 times (3.
0%) of the main peak area of the control solution, and the peak area of other single impurities should not be larger than the main peak area of the control solution.
0.
5 times (0.
5%), and the sum of the peak areas of other impurities shall not be greater than the main peak area of the control solution (1.
0%)
.
Moisture Take this product and measure it according to the moisture determination method (General Rule 0832 First Method 1), and the moisture content should not exceed 5.
0%
.
Take 2.
0g of this product for heavy metals and inspect it according to the law (the third method of general rule 0821); if the test solution is colored and cannot be colored with dilute caramel, take 4.
0g of this product, add 10ml of sodium hydroxide test solution and 20ml of water After dissolving, divide into two equal parts A and B, add water to tube B to make 25ml, add 5 drops of sodium sulfide test solution to tube A, shake well, filter through a filter membrane (pore size 3μm), and then add 2ml of standard lead solution to tube A , add water to make 25ml, and then add 5 drops of sodium sulfide test solution to each of the A and B tubes.
By comparison, the heavy metal content should not exceed 10 parts per million
.
Arsenic salt take 1.
0g of this product, add 1.
0g of calcium hydroxide, mix, add 2ml of water, stir evenly, after drying, slowly burn it with a small fire until it is completely carbonized, then burn at 500~600℃ to make it gray-white, put it aside Cold, add 5ml of hydrochloric acid and 23ml of water, check according to the law (the first method of General Principle 0822), it should meet the regulations (0.
0002%)
12 Appearance: White or off-white crystalline powder
.
Solubility: easily soluble in water, slightly soluble in ethanol, almost insoluble in dichloromethane
.
[Check] Alkalinity Take 0.
10g of this product, dissolve it in 100ml of water, and measure it according to the law (General Rule 0631).
The pH value should be 9.
5~10.
5
.
For the clarity and color of the solution, take 1.
0g of this product, add 10ml of water to dissolve it, and check it according to the law (General Rule 0902), the solution should be clear; No deeper
.
For chloride, take 2.
0g of this product, add 40ml of water to dissolve, adjust the solution to neutrality with dilute nitric acid, dilute to 50ml with water, shake, filter, take 5.
0ml of the filtrate, check according to the law (General Rule 0801), and compare with standard chlorination Compared with the control solution made of 7.
0ml of sodium solution, it should not be more concentrated (0.
035%)
.
Sulfate Take 25ml of the subsequent filtrate under the chloride item and check according to the law (General Rule 0802).
Compared with the control solution made of 2.
4ml of standard potassium sulfate solution, it should not be more concentrated (0.
024%)
.
Take an appropriate amount of this product for related substances, dissolve and dilute it with mobile phase to make a solution containing 1.
0 mg per 1 ml, as the test solution; accurately measure an appropriate amount, dilute with mobile phase to prepare a solution containing 10 μg per 1 ml, as control solution
.
According to the chromatographic conditions under the content determination item, take 20 μl of the control solution and inject it into the liquid chromatograph, record the chromatogram, the signal-to-noise ratio of the main component peak height should be greater than 10; then precisely measure 20 μl of the test solution and the control solution, respectively.
Inject into the liquid chromatograph, record the chromatogram to 4 times the retention time of the main component peak
.
If there is a peak consistent with the retention time of the p-hydroxybenzoic acid peak in the chromatogram of the test solution, its peak area should not be greater than 3 times (3.
0%) of the main peak area of the control solution, and the peak area of other single impurities should not be larger than the main peak area of the control solution.
0.
5 times (0.
5%), and the sum of the peak areas of other impurities shall not be greater than the main peak area of the control solution (1.
0%)
.
Moisture Take this product and measure it according to the moisture determination method (General Rule 0832 First Method 1), and the moisture content should not exceed 5.
0%
.
Take 2.
0g of this product for heavy metals and inspect it according to the law (the third method of general rule 0821); if the test solution is colored and cannot be colored with dilute caramel, take 4.
0g of this product, add 10ml of sodium hydroxide test solution and 20ml of water After dissolving, divide into two equal parts A and B, add water to tube B to make 25ml, add 5 drops of sodium sulfide test solution to tube A, shake well, filter through a filter membrane (pore size 3μm), and then add 2ml of standard lead solution to tube A , add water to make 25ml, and then add 5 drops of sodium sulfide test solution to each of the A and B tubes.
By comparison, the heavy metal content should not exceed 10 parts per million
.
Arsenic salt take 1.
0g of this product, add 1.
0g of calcium hydroxide, mix, add 2ml of water, stir evenly, after drying, slowly burn it with a small fire until it is completely carbonized, then burn at 500~600℃ to make it gray-white, put it aside Cold, add 5ml of hydrochloric acid and 23ml of water, check according to the law (the first method of General Principle 0822), it should meet the regulations (0.
0002%)
