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Medicinal sucrose 25kg COFCO filing registration A [identification] (1) Take this product, add 0.
05mol/L sulfuric acid solution, boil, neutralize with 0.
1mol/L sodium hydroxide solution, and then add alkaline copper tartaric acid test solution, heating to generate a red precipitate
of copper oxide.
(2) The infrared light absorption pattern of this product should be consistent with the map of the sucrose control (General Principle 0402
).
【Inspection】 The color of the solution Take 5g of this product, add 5ml of water to dissolve, if the color is developed, compared with the yellow No.
4 standard colorimetric solution (general principle 0901 first method), it must not be deeper
.
Sulfate Take 1.
0g of this product, check according to law (general 0802), and compare with the control solution made of standard potassium sulfate solution 5.
0ml, no more concentrated (0.
05%)
.
Reducing sugar Take 5.
0g of this product, placed in a 250ml Erlenmeyer flask, add 25ml of water to dissolve, precisely add 25ml of alkaline copper citrate test solution with a few glass beads, heat reflux to make it boil within 3 minutes, from the time of full boiling, continuous boiling for 5 minutes, quickly cool to room temperature (at this time, care should be taken not to make the copper oxide in the bottle in contact with air), immediately add 25% potassium iodide solution 15ml, shake well, with vibration slowly add sulfuric acid solution (1→5) 25ml, Immediately after the carbon dioxide is stopped, it is titrated with sodium thiosulfate titration solution (0.
1mol/L), and at the near end point, add 2ml of starch indicator solution, continue to titrate until the blue disappears, and do a blank test
at the same time.
The volume difference between the two consuming sodium thiosulfate titration solution (0.
1 mol/L) should not exceed 2.
0 ml (0.
10%)
.
Blazing residue Take 2.
0g of this product, check according to law (General Principle 0841), and the residual residue shall not exceed 0.
1%.
Calcium salt Take 1.
0g of this product, add 25ml of water to dissolve, add 1ml of ammonia test solution and 5ml of ammonium oxalate test solution, shake well, leave for 1 hour, with calcium standard solution (precision weigh calcium carbonate 0.
125g, placed in a 500ml measuring bottle, add 5ml of water and 0.
5ml of hydrochloric acid to dissolve, add water to the scale, shake well
.
Each lml corresponds to 0.
10 mg of Ca) 5.
0 ml of the control solution compared, no more concentrated (0.
05%)
.
Heavy metals Take the residues left under the burning residue and inspect them according to law (General Principle 0821 Second Law), and the heavy metals shall not exceed 5
parts per million.
【Category】Medicinal excipients, flavoring agents and adhesives, etc