Take 10 empty capsules, gently pinch both ends of the capsule with your thumb and forefinger, rotate and pull to avoid sticking, deformation and breakage.
Then fill the capsules with talcum powder, cover the bottle cap and bottle body, and drop the capsules one by one on a board with a thickness of 2cm and a height of 1m, so as not to leak powder. If a small number of powder leaks, do not exceed 2 tablets. If there are more than 10 times, another 10 retests should be carried out, which should meet the requirements.
Take 50 pieces of this product, put it into a glass cup, transfer it into a dryer with saturated magnesium nitrate solution, keep it at 25℃～1℃ for 24 hours, put it into a glass tube (2cm thick) standing on the plate, put the cylindrical Shaped weights (made of polytetrafluoroethylene, diameter 22mm, weight 20g ± 0.1g) are freely placed from the glass tube mouth, according to whether the capsule is ruptured, if there is rupture, no more than 15 pieces.
3) Dismantling time limit:
Take 6 tablets of this product, fill in talcum powder, and check according to the disintegration time limit test method (Appendix X) and the capsule method. Each tablet should completely dissolve or disintegrate within 10 minutes.
If 1 tablet cannot be completely dissolved or disintegrated, another 6 tablets should be taken for re-inspection, and the re-inspection should meet the requirements.
4) Sulfites (so <> counts)
Replace 5.0g of product, dissolve it in 100ml of water in a long-necked round-bottomed flask, add 2ml of phosphoric acid and 0.5g of sodium bicarbonate, immediately connect a condenser tube, take 15ml of 0.1mol/L iodine solution as the collection liquid, collect 50ml of fractions, and add 100ml of water, Shake well, measure 50ml, put it in a water bath to evaporate, add an appropriate amount of water at any time to evaporate, until the solution is almost colorless.
Add water to 40 ml and check for sulfuric acid according to the test method (Appendix VIII b). If cloudy, the concentration of the standard potassium sulfate solution should not be 3.75 mL of the control solution (0.01%).
Take an appropriate amount of chloroethane, accurately weigh it, add n-hexane to dissolve, and quantitatively dilute to a solution of about 22°g per milliliter; accurately weigh 2ml, put it into a separatory funnel containing 24ml of n-hexane, add 2ml of purified water, shake Extracted uniformly, and the aqueous solution was the control solution. Take another appropriate amount of capsules, cut them into slices, weighing 2.5g, put them in a conical stopper, add 25ml of n-hexane, soak overnight, put the n-hexane solution into a separatory funnel, add 2ml of water, and the solution is for pumping and boosting Shake, an aqueous solution is an example of a solution.
6) Check by gas chromatography (Appendix VE)
Use a 15% PEG-1500 (or 10% PEG-20M) column with a length of 2M and a column temperature of 110℃. The peak area or peak height of chloroethane in the test solution shall not exceed that of the control solution (applicable to the ethylene oxide sterilization process).
7) Drying loss:
Take 1.0g of this product, separate the cap from the bottle, and dry at 105°C for 6 hours. Weight loss ranges from 12.5% - 17.5%.
8) Ignition residue:
Take 1.0g of this product and inspect it according to the law (Appendix VIII n). Residual residue (transparent) must not exceed 2.0%, one part (translucent or transparent opaque part) 3.0%, 4.0% (one-part, translucent and opaque other part), 5.0% (other opaque part).
9) Heavy metals:
Residues remain in the combustion residue and are checked according to the law (Appendix VIII h, method 2). Heavy metal content should not exceed 50ppm.
Take 4.50g of this product, put it in a 100ml beaker, set the weight, add 20ml of warm water, put it in a 60°C water bath, and stir to dissolve.
Take out the beaker, dry the outer wall, and add water to make the total weight of the glue solution reach the weight of the following formula (including 15.0% dry product). Mix the glue evenly, pour it into a dry conical flask with a stopper, tighten the stopper, place it in a water bath at 40°C ± 0.1°C, and put it into a bungalow viscometer after about 10 minutes. According to the viscosity measurement method (Appendix g, method 1, the inner diameter of the capillary is 2.0mm), the kinematic viscosity of the product measured in a water bath at 40°C and 0.1°C should not be less than 60mm<2>/s. (1 loss on drying) × 4.50 × 100 Total glue weight (g) = - 15.0
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