Pharmaceutical Excipient Pregelatinized Starch Medical Grade Compressible Starch Drug Approval Number Registered Certificate Manufacturer PS Direct Compression Starch Pregelatinized Starch Manufacturer

Pregelatinized Starch This product is prepared by processing starch through physical methods to improve its flowability and compressibility. 

【Description】 This product is a white or off-white powder.

【Identification】 (1) Take about 1g of the product, add 15ml of water, stir, boil, and cool to form a transparent or semi-transparent off-white gel.     (2) Take about 0.1g of the product, add 20ml of water, mix well, add a few drops of iodine test solution, which should show blue-black, blue, purple, or purplish-red color, fading gradually upon heating.

【Tests】Acidity Take 10.0g of the product, add 10ml of neutral ethanol (neutral to phenolphthalein indicator), shake well, add 100ml of water, stir for 5 minutes, and determine as specified (General Rule 0631). The pH should be between 4.5 and 7.0. Sulfur Dioxide Take an appropriate amount of the product and test as specified (General Rule 2331). The sulfur dioxide content should not exceed 0.004%.     Oxidizing Substances Take 5.0g of the product, add 20ml of a methanol-water (1:1) mixture, then add 1ml of 6mol/L acetic acid solution, stir well, centrifuge, precisely add 0.5ml of freshly prepared saturated potassium iodide solution, let stand for 5 minutes. The supernatant and precipitate should not show obvious blue, brown, or purple color.     Loss on Drying Dry the product at 120°C for 4 hours; the loss in weight should not exceed 14.0% (General Rule 0831). Take 1.0g of the product and test as specified (General Rule 2302); the residue should not exceed 0.3%.     Heavy Metals Take 1.0g of the sample and test as specified (General Rule 0821, Method II); the heavy metal content should not exceed 20 parts per million.     Iron Salts Take 0.50g of the product, add 4ml of dilute acid and 16ml of water, shake for 5 minutes, filter, wash with a small amount of water, combine the filtrate and washings, add 50mg of ammonium persulfate, dilute with water to 35ml, and test as specified (General Rule 0807). The color should not be deeper than that of a control solution prepared with 1.0ml of standard iron solution (0.002%). Microbial Limits Take the product and test as specified (General Rule 1105 and General Rule 1106). The total aerobic microbial count should not exceed 1000 cfu per gram, the total combined molds and yeasts count should not exceed 100 cfu per gram, and Escherichia coli should not be detected. 

【Category】Pharmaceutical excipient, filler, and disintegrant, etc.

【Storage】Keep tightly closed.