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Medicinal grade mannitol 25kg flavor filler [check] Take 0g of this product for acidity, add 50ml of water to dissolve, add 3 drops of phenolphthalein indicator solution and 30ml of sodium hydroxide titration solution (02mol/L), it should be pink colo.
Clarity and color of solution Take 5g of this product, add 10ml of water to dissolve, the solution should be clear and colorless; if it is turbid, it should not be more concentrated thanN.
Relevant substances shall be determined according to high performance liquid chromatography (General Rule 0512.
Test solution solution Take this product, dissolve in water and dilute to make a solution containing 50mg per 1m.
Control solution Precisely measure 1ml of the test solution, put it in a 100ml volumetric flask, and dilute to the mark with wate.
System suitability solution Take 5g of mannitol and sorbitol each, put them in the same 100ml measuring bottle, add water to dissolve and dilute to the mar.
Chromatographic conditions: Strong cationic calcium exchange column (or chromatographic column with equivalent separation efficiency) with sulfonated cross-linked styrene-divinylbenzene copolymer as filler; water as mobile phase; flow rate of 5ml per minute; column The temperature is 80 °C; the differential refractive index detector, the detection temperature is 55 °C; the injection volume is 20 μ.
System suitability requirements In the system suitability solution chromatogram, the resolution between the mannitol peak and the sorbitol peak should be greater than 0.Determination method Precisely measure the test solution and the control solution, inject them into a liquid chromatograph, and record the chromatogram to twice the retention time of the main component pea.
Limits If there are impurity peaks in the chromatogram of the test solution, the sum of the areas of each impurity peak shall not be greater than 2 times (0%) of the main peak area of the control solution, and the chromatographic peaks less than 05 times the main peak area of the control solution shall be ignore.
Take 0g of this product as reducing sugar, put it in a conical flask, add 25ml of water to dissolve, add copper citrate solution (take 25g of copper sulfate, 50g of citric acid and 144g of anhydrous sodium carbonate, add 1000ml of water to dissolve, that is, ) 20ml, heat to boiling, keep boiling for 3 minutes, cool rapidly, add 100ml of 4% (V/V) glacial acetic acid solution and 20ml of 025mol/L iodine titration solution, shake well, add 6% (V/V) hydrochloric acid 25ml of solution (precipitate should be completely dissolve.
If there is precipitation, continue to add the hydrochloric acid solution until the precipitate is completely dissolved), titrate with sodium thiosulfate titration solution (05mol/L), add 1ml of starch indicator solution near the end point, and continue to titrate to Blue disappear.
The volume of sodium thiosulfate titrant (05mol/L) consumed shall not be less than 18m.
Chloride Take 0g of this product and inspect it according to the law (general rule 0801.
Compared with the control solution made of 0ml of standard sodium chloride solution, it should not be more concentrated (003%.
Sulfate Take 0g of this product and inspect it according to the law (General Rule 0802.
Compared with the control solution made of 0ml of standard potassium sulfate solution, it should not be more concentrated (01%.
Take 0g of this product for oxalate, add 6ml of water, heat to dissolve, let it cool, add 3 drops of ammonia test solution and 1ml of calcium chloride test solution, shake well, heat it in a water bath for 15 minutes, take it out, and let it cool; such as When turbidity occurs, mix with sodium oxalate solution [take 1523g of sodium oxalate, put it in a 1000ml measuring bottle, add water to dissolve and dilute to the mark, shake wel.
Each 1ml is equivalent to 1mg of oxalate (C2O4)] 0ml shall not be more concentrated (02%) than the control solution made by the same metho.
Loss on drying Take this product and dry it at 105℃ to constant weight, the weight loss should not exceed 5% (General Rule 0831
Clarity and color of solution Take 5g of this product, add 10ml of water to dissolve, the solution should be clear and colorless; if it is turbid, it should not be more concentrated thanN.
Relevant substances shall be determined according to high performance liquid chromatography (General Rule 0512.
Test solution solution Take this product, dissolve in water and dilute to make a solution containing 50mg per 1m.
Control solution Precisely measure 1ml of the test solution, put it in a 100ml volumetric flask, and dilute to the mark with wate.
System suitability solution Take 5g of mannitol and sorbitol each, put them in the same 100ml measuring bottle, add water to dissolve and dilute to the mar.
Chromatographic conditions: Strong cationic calcium exchange column (or chromatographic column with equivalent separation efficiency) with sulfonated cross-linked styrene-divinylbenzene copolymer as filler; water as mobile phase; flow rate of 5ml per minute; column The temperature is 80 °C; the differential refractive index detector, the detection temperature is 55 °C; the injection volume is 20 μ.
System suitability requirements In the system suitability solution chromatogram, the resolution between the mannitol peak and the sorbitol peak should be greater than 0.Determination method Precisely measure the test solution and the control solution, inject them into a liquid chromatograph, and record the chromatogram to twice the retention time of the main component pea.
Limits If there are impurity peaks in the chromatogram of the test solution, the sum of the areas of each impurity peak shall not be greater than 2 times (0%) of the main peak area of the control solution, and the chromatographic peaks less than 05 times the main peak area of the control solution shall be ignore.
Take 0g of this product as reducing sugar, put it in a conical flask, add 25ml of water to dissolve, add copper citrate solution (take 25g of copper sulfate, 50g of citric acid and 144g of anhydrous sodium carbonate, add 1000ml of water to dissolve, that is, ) 20ml, heat to boiling, keep boiling for 3 minutes, cool rapidly, add 100ml of 4% (V/V) glacial acetic acid solution and 20ml of 025mol/L iodine titration solution, shake well, add 6% (V/V) hydrochloric acid 25ml of solution (precipitate should be completely dissolve.
If there is precipitation, continue to add the hydrochloric acid solution until the precipitate is completely dissolved), titrate with sodium thiosulfate titration solution (05mol/L), add 1ml of starch indicator solution near the end point, and continue to titrate to Blue disappear.
The volume of sodium thiosulfate titrant (05mol/L) consumed shall not be less than 18m.
Chloride Take 0g of this product and inspect it according to the law (general rule 0801.
Compared with the control solution made of 0ml of standard sodium chloride solution, it should not be more concentrated (003%.
Sulfate Take 0g of this product and inspect it according to the law (General Rule 0802.
Compared with the control solution made of 0ml of standard potassium sulfate solution, it should not be more concentrated (01%.
Take 0g of this product for oxalate, add 6ml of water, heat to dissolve, let it cool, add 3 drops of ammonia test solution and 1ml of calcium chloride test solution, shake well, heat it in a water bath for 15 minutes, take it out, and let it cool; such as When turbidity occurs, mix with sodium oxalate solution [take 1523g of sodium oxalate, put it in a 1000ml measuring bottle, add water to dissolve and dilute to the mark, shake wel.
Each 1ml is equivalent to 1mg of oxalate (C2O4)] 0ml shall not be more concentrated (02%) than the control solution made by the same metho.
Loss on drying Take this product and dry it at 105℃ to constant weight, the weight loss should not exceed 5% (General Rule 0831
