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Main efficacy and function of pharmaceutical grade sodium caprylate XinsuannaSodium Caprylate This product is calculated as anhydrous and contains not less than 99.
0% C8H15NaO2
.
【Properties】This product is white or off-white crystalline powder
.
This product is easily soluble in water or glacial acetic acid, slightly soluble in ethanol, and almost insoluble in acetone
.
[Identification] (1) Take about 20mg of this product, add 0.
5ml of water to dissolve, add methoxyl test solution (take 2.
7g of methoxyl group, add 6ml of 10% tetramethylammonium hydroxide methanol solution to dissolve, add 20ml of ethanol , shake well, store in a polyethylene container) 1.
5ml, cool in an ice bath for 30 minutes to form a large amount of white crystalline precipitate; put it in a water bath at 20 ℃, stir for 5 minutes, the precipitate does not disappear; add ammonia test solution 1ml, The precipitate was completely dissolved; 1 ml of 16% ammonium carbonate solution was added, and no precipitate was formed
.
(2) In the chromatogram recorded under the related substances, 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】Alkalinity Take 2.
5g of this product, dissolve it in 25ml of water, and measure it according to the law (General Rule 0631).
The pH value should be 8.
0 to 10.
5
.
The clarity and color of the solution take 2.
5g of this product, add 25ml of water to dissolve it, and check it according to the law (general rule 0901 and general rule 0902), the solution should be clear and colorless; One method) comparison, must not go deeper
.
Moisture Take this product and measure it according to the moisture determination method (the first method of General Rule 0832), and the moisture content shall not exceed 3.
0%
.
Heavy Metals Take 2.
0g of this product, add glacial acetic acid-water-ethanol (5:10:85) to dissolve and dilute to 25ml, check according to the law (the first method of general rule 0821), and the heavy metal content should not exceed 5ppm
.
Take about 0.
12g of this product for related substances, add 5ml of water to dissolve, add 1ml of dilute sulfuric acid, shake well, add 10ml of ethyl acetate, shake to extract, let stand for separation, take the ethyl acetate layer, add anhydrous sodium sulfate After drying, take the supernatant as the test solution; accurately measure 1ml, put it in a 100ml measuring bottle, dilute it to the mark with ethyl acetate, shake well, accurately measure 5ml, put it in a 50ml measuring bottle, use ethyl acetate Dilute to the mark, shake well, and use it as a reference solution; take another 10 mg of octanoic acid reference substance, accurately weigh it, and add 10 ml of ethyl acetate to dissolve it as a reference substance solution
.
According to the test of gas chromatography (General Rule 0521), a capillary column with 2-nitroterephthalic acid-modified polyethylene glycol 20M (or similar polarity) as the stationary liquid is used as the chromatographic column (30m×0.
25mm, 0.
25μm or a chromatographic column with equivalent performance); the initial temperature is 100 °C, maintained for 1 minute, and the temperature is increased to 220 °C at a rate of 5 °C per minute, maintained for 20 minutes; the inlet temperature is 250 °C; the detector temperature is 250 °C
.
Take 1 μl of the control solution and inject it into the gas chromatograph, and the signal-to-noise ratio of the chromatographic peaks of the principal components should not be less than 5
.
Take 1 μl of the test solution and inject it into a gas chromatograph, record the chromatogram, and calculate according to the area normalization method
.
If there are impurity peaks in the chromatogram of the test solution, the single impurity shall not exceed 0.
3%, and the total impurity shall not exceed 0.
5%
.
Any peak smaller than 0.
5 times the area of the main peak in the control solution in the chromatogram of the test solution is ignored
.
Bacterial endotoxin (for injection) Take this product and inspect it according to the law (General Rule 1143).
The amount of endotoxin contained in each 1 mg of sodium caprylate should be less than 0.
3EU
.
[Determination of content] Take about 0.
15g of this product, accurately weigh it, add 50ml of glacial acetic acid to dissolve it, titrate with perchloric acid titration solution (0.
1mol/L) according to the potentiometric titration method (General Rule 0701), and compare the results of the titration Correction with blank test
.
Each 1ml of perchloric acid titration solution (0.
1mol/L) is equivalent to 16.
62mg of C8H15NaO2
.
【Category】Pharmaceutical excipients, stabilizers and bacteriostatic agents,
etc.
【Storage】Airtight, keep in cool and dark place
.
0% C8H15NaO2
.
【Properties】This product is white or off-white crystalline powder
.
This product is easily soluble in water or glacial acetic acid, slightly soluble in ethanol, and almost insoluble in acetone
.
[Identification] (1) Take about 20mg of this product, add 0.
5ml of water to dissolve, add methoxyl test solution (take 2.
7g of methoxyl group, add 6ml of 10% tetramethylammonium hydroxide methanol solution to dissolve, add 20ml of ethanol , shake well, store in a polyethylene container) 1.
5ml, cool in an ice bath for 30 minutes to form a large amount of white crystalline precipitate; put it in a water bath at 20 ℃, stir for 5 minutes, the precipitate does not disappear; add ammonia test solution 1ml, The precipitate was completely dissolved; 1 ml of 16% ammonium carbonate solution was added, and no precipitate was formed
.
(2) In the chromatogram recorded under the related substances, 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】Alkalinity Take 2.
5g of this product, dissolve it in 25ml of water, and measure it according to the law (General Rule 0631).
The pH value should be 8.
0 to 10.
5
.
The clarity and color of the solution take 2.
5g of this product, add 25ml of water to dissolve it, and check it according to the law (general rule 0901 and general rule 0902), the solution should be clear and colorless; One method) comparison, must not go deeper
.
Moisture Take this product and measure it according to the moisture determination method (the first method of General Rule 0832), and the moisture content shall not exceed 3.
0%
.
Heavy Metals Take 2.
0g of this product, add glacial acetic acid-water-ethanol (5:10:85) to dissolve and dilute to 25ml, check according to the law (the first method of general rule 0821), and the heavy metal content should not exceed 5ppm
.
Take about 0.
12g of this product for related substances, add 5ml of water to dissolve, add 1ml of dilute sulfuric acid, shake well, add 10ml of ethyl acetate, shake to extract, let stand for separation, take the ethyl acetate layer, add anhydrous sodium sulfate After drying, take the supernatant as the test solution; accurately measure 1ml, put it in a 100ml measuring bottle, dilute it to the mark with ethyl acetate, shake well, accurately measure 5ml, put it in a 50ml measuring bottle, use ethyl acetate Dilute to the mark, shake well, and use it as a reference solution; take another 10 mg of octanoic acid reference substance, accurately weigh it, and add 10 ml of ethyl acetate to dissolve it as a reference substance solution
.
According to the test of gas chromatography (General Rule 0521), a capillary column with 2-nitroterephthalic acid-modified polyethylene glycol 20M (or similar polarity) as the stationary liquid is used as the chromatographic column (30m×0.
25mm, 0.
25μm or a chromatographic column with equivalent performance); the initial temperature is 100 °C, maintained for 1 minute, and the temperature is increased to 220 °C at a rate of 5 °C per minute, maintained for 20 minutes; the inlet temperature is 250 °C; the detector temperature is 250 °C
.
Take 1 μl of the control solution and inject it into the gas chromatograph, and the signal-to-noise ratio of the chromatographic peaks of the principal components should not be less than 5
.
Take 1 μl of the test solution and inject it into a gas chromatograph, record the chromatogram, and calculate according to the area normalization method
.
If there are impurity peaks in the chromatogram of the test solution, the single impurity shall not exceed 0.
3%, and the total impurity shall not exceed 0.
5%
.
Any peak smaller than 0.
5 times the area of the main peak in the control solution in the chromatogram of the test solution is ignored
.
Bacterial endotoxin (for injection) Take this product and inspect it according to the law (General Rule 1143).
The amount of endotoxin contained in each 1 mg of sodium caprylate should be less than 0.
3EU
.
[Determination of content] Take about 0.
15g of this product, accurately weigh it, add 50ml of glacial acetic acid to dissolve it, titrate with perchloric acid titration solution (0.
1mol/L) according to the potentiometric titration method (General Rule 0701), and compare the results of the titration Correction with blank test
.
Each 1ml of perchloric acid titration solution (0.
1mol/L) is equivalent to 16.
62mg of C8H15NaO2
.
【Category】Pharmaceutical excipients, stabilizers and bacteriostatic agents,
etc.
【Storage】Airtight, keep in cool and dark place
.
