1) Tightness:
Take 10 capsules of this product, gently pinch both ends of the capsule with your thumb and index finger, rotate and pull it open, there shall be no bonding, deformation or cracking, and then fill it with talcum powder, put the cap and body together, and fall straight on the wooden board with a thickness of 2cm at a height of 1m one by one, and there should be no powder leakage; if there is a small amount of powder leakage, it shall not exceed 2 grains. If it is exceeded, another 10 capsules should be taken for retest, which should comply with the regulations.
2) Brittleness:
Take 50 grains of this product, put them in a surface dish, move them into a dryer containing magnesium nitrate saturated solution, put them at a constant temperature of 25 °C ± 1 °C for 24 hours, take them out, and immediately put them into the glass tube (inner diameter of 24nm and length of 200nm) standing upright on the wooden board (thickness of 2cm) one by one, and the cylindrical weight (made of polytetrafluoroethylene, diameter of 22mm, weight of 20g±0.1g) falls freely from the mouth of the glass tube, depending on whether the capsule is broken, if it is broken, it shall not exceed 15 capsules.
3) Disintegration Time Limit:
Take 6 capsules of this product, fill them with talcum powder, and check them according to the disintegration time inspection method (Appendix X. A), the method under the capsule dome, and each grain should be completely dissolved or disintegrated within 10 minutes. If 1 grain cannot be fully dissolved or disintegrated, another 6 capsules should be taken for retest, all of which should comply with the regulations.
4) Sulfite (based on SO<[2]>): take 5.0g of this product, put it in a long-necked round-bottom flask, heat 100ml of water to dissolve, add 2ml of phosphoric acid and 0.5g of sodium bicarbonate, immediately connect the condenser tube, take 15ml of 0.1mol/L iodine solution as the receiving solution, collect 50ml of distillate, add water to 100ml, shake well, take 50ml, evaporate on a water bath, add an appropriate amount of water at any time, steam until the solution is almost colorless, add water to 40ml, and follow the sulfate inspection method (Appendix VIII. B) Inspection, if turbid, should not be more concentrated (0.01%) than the control solution made of 3.75ml of standard potassium sulfate solution.
5) Chloroethanol: take an appropriate amount of chloroethanol, weigh it accurately, add n-hexane to dissolve and quantitatively dilute it into a solution containing about 22 μg per 1ml; take 2ml accurately, place it in a separating funnel containing 24ml of n-hexane, add 2ml of water accurately, shake to extract, and take the aqueous solution as the control solution. Take an appropriate amount of capsules, cut them into pieces, weigh 2.5g, put them in a stopper flask, add 25ml of n-hexane, impregnate overnight, move the n-hexane solution to the separating funnel, add 2ml of water precisely, shake to extract, and take the aqueous solution as the test solution.
6) Photographic chromatography (Appendix V. E) check: Measured with a 15% polyethylene glycol-1500 (or 10% polyethylene glycol-20M) column with a column length of 2 M, at a column temperature of 110 °C. The peak area or peak height of chloroethanol in the test solution shall not exceed the peak area or peak height of the control solution (this item is applicable to the ethylene oxide sterilization process).
7) Loss on drying: take 1.0g of this product, separate the cap and body, and dry it at 105°C for 6 hours, and the weight loss should be 12.5%~17.5%.
8) Residue on ignition: take 1.0g of this product, check according to law (Appendix VIII. N), and the residual residue shall not exceed 2.0% (transparent), 3.0% (translucent or transparent in one section, opaque in another), 4.0% (translucent in one section, opaque in the other section), and 5.0% (opaque).
9) Heavy metals: take the residues left under the ignition residue and inspect them according to law (Appendix VIII. H Law 2), and the heavy metals shall not exceed 50 parts per million.
10) Viscosity: take 4.50g of this product, put it in a 100ml beaker that has been weighed, add 20ml of warm water, and stir it in a 60°C water bath to dissolve. Take out the beaker, dry the outer wall, add water to make the total weight of the glue reach the weight of the following formula (including 15.0% of the dry product), stir the glue well, pour it into a dry Erlenmeyer flask with stopper, plug it, put it in a water bath at 40 °C ± 0.1 °C, about 10 minutes later, move it to the Pinnaut viscometer, and measure it in a water bath at 40 °C ± 0.1 °C, according to the viscosity determination method (Appendix VI. G The first method, the inner diameter of the capillary is 2.0mm), and the kinematic viscosity of this product shall not be less than 60mm<2>/s. (1-loss on drying)× 4.50×100 total weight of glue (g) = ──15.0
