Medical grade pre-gelatinized starch experiment declaration research and development test

Medical grade pregelatinized starch experimental declaration research and development of small trial pregelatinized starch Yujiaohua Dianfen Pregelatinized Starch This strain of starch is prepared by physical processing to improve its fluidity and compressibility
.

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

【Identification】 (1) Take this product, load the tablets with glycerol-water (1.
.
.
1), observe under the microscope, partially or completely lose the original shape of the starch, and show irregular particles or flakes; Observed under polarized light, the polarized cross of some or all of the particles disappears
.

(2) Take about 1g of this product, add 15ml of water, stir, boil, let cool, that is, into a transparent or translucent white gel
.

(3) Take about 0.
1g of this product, add 20ml of water, mix well, add a few drops of iodine test solution, that is, bluish black, blue, purple or purple red, and gradually fade
after heating.

【Inspection】 Acidity Take 10.
0g of this product, add neutral ethanol (neutral to phenolphthalein indicator solution) 10ml, shake well, add 100ml of water, stir for 5 minutes, determine according to law (general 0631), pH value should be 4.
5 ~ 7.
0
.

Sulfur dioxide Take an appropriate amount of this product, check according to law (General Principle 2331 First Law), sulfur dioxide content shall not exceed 0.
004%.
Oxidizing substances Take 5.
0g of this product, add 20ml of methanol- water (1.
.
1) mixture, add 6mol/L acetic acid solution 1ml, stir well, centrifuge, precision add new saturated potassium iodide solution 0.
5ml, leave for 5 minutes, supernatant and precipitate must not have obvious blue, brown or purple
.

Loss on drying Take this product, dry at 120 ° C for 4 hours, the weight loss shall not exceed 14.
0% (General 0831).
Burning residue Take l.
0g of this product, check according to law (General Principle 0841), and the residual residue shall not exceed 0.
5%.
Iron salt Take 0.
50g of this product, add 4ml of dilute hydrochloric acid with 16ml of water, shake for 5 minutes, filter, wash with a small amount of water, combine filtrate and lotion, add ammonium persulfate 50mg, dilute into 35ml with water, check according to law (general 0807), compared with the control solution made of standard iron solution 1.
0ml, not deeper (0.
002%)
.

Heavy metals Take the residue left under the burning residue and inspect it according to law (General Principle 0821 Second Law), and the heavy metal shall not exceed 20 parts per million
.

Microbial limits Take this product, check according to law (General Principle 1105 and General Principle 1106), the total number of aerobic bacteria in each 1g of the test product shall not exceed 103cfu, the total number of mold and yeast shall not exceed 102cfu, and Escherichia coli
shall not be detected.

【Category】Pharmaceutical excipients, fillers, disintegrates and adhesives, etc