Pharmaceutical grade pregelatinized starch 25kg compressible starch

【Check】Acidity Take 10g of this product, add 10ml of neutral ethanol (neutral to phenolphthalein indicator solution), shake well, add 100ml of water, stir for 5 minutes, and measure according to the law (General Rule 0631.
The pH value should be 5 to 0.Sulfur dioxide Take an appropriate amount of this product and inspect it according to the law (the first method of General Rule 2331), and the content of sulfur dioxide should not exceed 004.
Oxidizing substances take 0g of this product, add 20ml of methanol-water (1:1) mixture, add 1ml of 6mol/L acetic acid solution, stir evenly, centrifuge, add 5ml of newly prepared saturated potassium iodide solution, and leave it for 5 minute.
The supernatant and pellet must not have a distinct blue, brown or purple colo.
Weight loss on drying Take this product and dry it at 120℃ for 4 hours, the weight loss should not exceed 10% (General Rule 0831.
Residue on ignition Take 0g of this product and inspect it according to the law (General Rule 0841), and the residual residue should not exceed 5.
For iron salt, take 50g of this product, add 4ml of dilute hydrochloric acid and 16ml of water, shake for 5 minutes, filter, wash with a small amount of water, combine the filtrate and washing liquid, add 50mg of ammonium persulfate, dilute with water to 35ml, and check according to the law ( General rule 0807), should not be deeper (002%) compared to the control solution made of 0ml of standard iron solutio.
Heavy metals Take the residue left under the item of residue on ignition and inspect it according to the law (the second method of general rule 0821), and the heavy metal content shall not exceed 20 parts per millio.
Microbial limit Take this product and inspect it according to the law (general rule 1105 and general rule 1106), the total number of aerobic bacteria in each 1g of the test sample should not exceed 103cfu, the total number of mold and yeast should not exceed 102cfu, and Escherichia coli should not be detecte.
【Category】Pharmaceutical excipients, fillers, disintegrants and adhesives,et.
[Storage] Sealed and preserve.
【Marking】The starch source of this product should be marked, the particle size and particle size distribution, and the marked value of dissolved matter in water (which can be detected according to the attached method) should be marke.
Precisely measure 100ml of water dissolved in water, put 0g of this product in a beaker, accurately weigh it, slowly add it to the beaker while magnetic stirring, continue stirring for 10 minutes, take the dispersed solution, and rotate at a speed of 3000 revolutions per minut.
Centrifuge for 15 minute.
Precisely measure 25ml of the supernatant, put it in an evaporating dish dried to constant weight at 120°C, evaporate to dryness in a water bath, and dry at 120°C for 4 hour.
where A is the initial weight of the evaporating dish, g; B is the final weight of the evaporating dish, g;