Acidity of Pregelatinized Starch: Take 10.0g of this product, add 10ml of neutral ethanol (neutral to phenolphthalein indicator), shake well, then add 100ml of water that has been boiled and cooled, stir with a magnetic stirrer for 5 minutes, take the supernatant, and determine according to the method (Appendix VI H, Volume II, 2010 edition of the Chinese Pharmacopoeia). The pH value should be 4.5~7.0. Particle Size: Take 15.0g of this product, weigh it accurately, and check according to the method (Appendix Ⅸ E, second method), shaking back and forth for 15 minutes. The amount of sample that can pass through the No. 6 sieve should not be less than 90% of the sample, and the amount that cannot pass through the No. 3 sieve should not exceed 0.5% of the sample. Loss on Drying: Take this product, dry it at 120℃ for 4 hours, and the weight loss should not exceed 14.0% (Appendix Ⅷ L, Volume II, 2010 edition of the Chinese Pharmacopoeia). Ash: Take 1.0g of this product, place it in a crucible that has been ignited to constant weight, weigh accurately, ignite gently until completely carbonized, gradually increase the temperature to 600~700℃, until completely ashed and constant weight. The ash content should not exceed 0.3%. Iron Salts: Take 0.50g 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 washings, add 50mg of ammonium persulfate, dilute to 35ml with water, and check according to the method (Appendix Ⅷ G, Volume II, 2010 edition of the Chinese Pharmacopoeia). Compared with the control solution prepared with 1.0ml of standard iron solution, it should not be deeper (0.002%). Sulfur Dioxide: Take 20.0g of this product, place it in a stoppered conical flask, add 200ml of water, shake thoroughly, filter, take 100ml of the filtrate, add 2ml of starch indicator solution, and titrate with iodine titrant (0.005mol/L). The amount of iodine titrant consumed should not exceed 1.25ml (0.004%). Oxides: Take 5g of this product, add 20ml of a methanol-water (1:1) mixture, then add 1ml of 6mol/L acetic acid solution, stir to form a uniform suspension, accurately add 0.5ml of freshly prepared saturated potassium iodide solution, mix well, and let stand for 5 minutes. There should be no obvious blue-brown or purple color (0.002%). [Microbial Limits]: Take this product and check according to the method (Appendix XI J, Volume II, 2010 edition of the Chinese Pharmacopoeia). Bacterial count ≤1000 cfu/g; mold and yeast count ≤100 cfu/g; Escherichia coli should not be detected. [Category]: Pharmaceutical excipient, disintegrant and filler, etc. [Storage]: Store in a dry place.

Pregelatinized starch is a modified starch obtained by chemically or mechanically breaking down starch granules partially or completely. In tablets, it is commonly used as a binder, diluent, and disintegrant. Pregelatinized starch has self-lubricating properties, and when used with other excipients, magnesium stearate should be added as a lubricant. This product is non-toxic and non-irritating, but large oral doses are harmful.

Pregelatinized starch is produced by chemically or mechanically breaking down starch granules partially or completely, giving the starch fluidity and direct compressibility. Pregelatinized starch is a modified starch, a white or off-white powder of appropriate coarseness, odorless, with a slightly special taste. In the pharmaceutical field, it is commonly used as a binder, diluent, and disintegrant in oral tablets and capsules.

Precautions for using pregelatinized starch:

1. Storage of pregelatinized starch should be in a cool, dry, and ventilated place;

2. When using dry binder to directly press the powder, the use of alkali metal salts of stearic acid (such as magnesium stearate) as lubricants should be minimized to avoid affecting the hardness of the tablets. If necessary, stearic acid can be used as a lubricant, which has a smaller adverse effect on the hardness of the tablets.