Medical grade soluble starch experiment application research and development trial

Medical grade soluble starch experiment declared the development of small test soluble starch Kerongxing DianfenSoluble Starch [9005-84-9] This line of starch is processed by acid hydrolysis and other methods to improve its solubility in water and obtained
.

【Properties】This product is white or off-white powder
.

This product dissolves in boiling water and is insoluble
in water or ethanol.

【Identification】(1) Take the appropriate amount of this product, use glycerin-water (1:1) to pack the tablets (General Principles 2001), and observe under the microscope, the soluble starch of the corn source is a single grain, polygonal granules, round or oval particles, with a diameter of 2 ~ 35 μm; The umbilical point is central, dotted or star-shaped; The lamination is not obvious; Observed under a polarized microscope, a polarized cross is revealed, with the cross located at the umbilical point of the
particle.

Cassava source soluble starch is mostly single-grained, round or oval, with a diameter of about 5 to 35 μm, and there is a depression next to it; The umbilical point is central, dot-shaped or linear, and the laminate lines are not obvious; Observed under a polarized microscope, a polarized cross is revealed, with the cross located at the umbilical point of the
particle.

Potato-derived soluble starch is a single grain, oval or pear-shaped, with a diameter of 30 to 100 μm, occasionally exceeding 100 μm; or round, size 10 ~ 35 μm; Occasionally, there are composite particles composed of 2 to 4 starch granules; Ovoid or pear-shaped granules with eccentric umbilical points; Rounded granular umbilical points without a center or slightly irregular umbilical points; Observed under a polarized light microscope, the cross is located at the umbilical point of the
particle.

(2) Take about 1g of this product, add 15ml of water, boil, put it cold, add 3 drops of iodine test solution, that is, blue-black, blue-purple, purple-red or red
.

【Check】 Iodine sensitivity Take 2.
5ml of the test solution under the clarity check, add 97.
5ml of water, add iodine titration solution (0.
005mol/L) 0.
50ml, shake well, the solution should be pure blue or purple red, add sodium thiosulfate titration solution (0.
01mol/L) 0.
50ml, the solution color should disappear
.

pH Take the solution of the cooled test product under the clarification check, and determine it according to law (General Rule 0631), and the pH value should be 6.
0 ~ 7.
5
.

Clarity of the solution Potato or tapioca starch Source: Take 1.
0g of this product, add 5ml of water, stir evenly, heat the water 95ml, boil for 2 minutes, immediately check according to law, the solution should be clarified; if it is turbid, immediately compare with the No.
3 turbidity standard (general rule 0902), it shall not be more concentrated
.

Corn starch source: Take 0.
5g of this product, add 5ml of water, stir well, heat water for 95ml, boil for 2 minutes, immediately compare with No.
4 turbidity standard (general rule 0902), not more concentrated
.

Reducing sugar Take 10.
0g of this product, add 100.
0ml of water, shake for 15 minutes, let it sit for 12 hours, filter with G4 glass vertical melting crucible, take 50.
0ml of filtrate, add 50ml of alkaline copper tartarate, boil for 2 minutes, filter with a 105 °C constant weight G4 glass vertical melting crucible, wash the precipitate with water until the wash is neutral, and then wash with ethanol and 60ml each, dry to constant weight
at 105 °C.

Potato starch source: residual residue shall not exceed 0.
15g; other starch source: residual residue shall not exceed 0.
25g
.

Chloride Take 1.
0g of this product, put it in a 100ml measuring bottle, add about 50ml of water, shake for 10 minutes, dilute with water to the scale, shake well, filter, take 5.
0ml of filtrate, check according to law (General 0801), compared with the control liquid made of standard sodium chloride solution 10.
0ml, it shall not be more concentrated (0.
2%)
.

Sulfate Take 20.
0ml of the continued filtrate under chloride, check according to law (General Rule 0802), and compare with the control solution made of 2.
0ml of standard potassium sulfate solution, it shall not be more concentrated (0.
1%)
.

Oxidizing substances Take 4.
0g of this product, place in a stopper Erlenmeylenmeyer flask, add 50.
0ml of water, dense plug, shake for 5 minutes, transfer into a 50ml plugged centrifuge tube, centrifuge to clarify, take the supernatant 30.
0ml, put iodine in a bottle, add glacial acetic acid 1ml and potassium iodide 1.
0g, dense stopper, shake well, place in a dark place for 30 minutes, titrate with sodium thiosulfate titer solution (0.
002mol/L) until the blue or purplish red disappears, And the results of the titration are corrected with a blank test (the blank test should be determined after 30 min of placement, plus 1 ml of starch indicator solution).


Each 1 ml of sodium thiosulfate titration solution (0.
002 mol/L) is equivalent to 34 μg of oxidizing material (measured in hydrogen peroxide H2O2), and the sodium thiosulfate titration solution (0.
002mol/L) consumed must not exceed 1.
4 ml (0.
002%)
.

Loss on drying Take this product, dry at 130 °C for 90 minutes, and the weight loss shall not exceed 13.
0% (General 0831).
Blazing residue Take 1.
0g of this product, inspect according to law (General Rule 0841), and the residual residue shall not exceed 0.
5%.
Iron salt Take 1.
0g of this product, place in a stopper Erlenmeyer flask, dilute 4ml of hydrochloric acid with water for 16ml, shake vigorously for 5 minutes, filter, wash with an appropriate amount of water, merge filtrate and wash solution into a 50ml Nalken cuvette tube, add 50mg of ammonium persulfate, dilute it into 35ml with water, check according to law (General 0807), and compare with the control liquid made of standard iron solution 1.
0ml, it shall not be deeper (0.
001%)
.

Heavy metals: Take the residues left under the incineration residue and inspect them according to law (General Rule 0821 Second Law), and the heavy metals shall not exceed 20
parts per million.

Arsenic salt Take 1.
0g of this product, add 21ml of water, boil, put it cold, add 5ml of hydrochloric acid, check according to law (General 0822 First Law), should comply with the provisions (0.
0002%)
.

Microbial limit Take this product, check according to law (General Rule 1105 and General Rule 1106), the total number of aerobic bacteria per 1g of test product shall not exceed 103cfu, the total number of molds and yeasts shall not exceed 102cfu, and Escherichia coli
shall not be detected.

【Category】Pharmaceutical excipients, thinners and adhesives, etc
.

【Storage】Sealed and preserved
.

【Labeling】The source
of starch of the product should be indicated.