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 apart, without sticking, deforming or breaking, then fill it with talcum powder, cover the bottle cap and body, and drop the capsules one by one. On a 2cm thick and 1m high wooden board, there is no leakage of powder. If there is a small amount of powder leakage, not more than 2 tablets. If more than 10 times, you should take another 10 retests and follow the regulations.
2) Fragility:
Take 50 pieces of this product, put them in the glasses, move them to the dryer filled with saturated magnesium nitrate solution, keep them at 25℃ and 1℃ for 24 hours, and put them one by one on a wooden board immediately after taking it out (thickness Put a cylindrical weight (made of polytetrafluoroethylene, diameter 22mm, weight 20g±0.1g) into the glass tube of 2cm) freely from the mouth of the glass tube. Depending on whether the capsule is broken or not, if there is a break, no more than 15 pieces.
3) Time limit for disintegration:
Take 6 tablets of the product, fill them with talcum powder, and check according to the disintegration time limit inspection method (Appendix Ⅹ) and method in the capsule. Each tablet should be completely dissolved or disintegrated within 10 minutes. If one tablet cannot be completely dissolved or disintegrated, another 6 tablets should be taken for review, and the review should meet the requirements.
4) Sulfite (SO<[2]> calculation):
Instead of 5.0 grams of product, it is dissolved in a long-necked round-bottom flask with 100 ml of water by heating, adding 2 ml of phosphoric acid and 0.5 g of sodium bicarbonate, immediately connecting the condenser tube, and taking 15 ml of 0.1 mol/L iodine solution as Receive the solution, collect 50 ml fractions, add 100 ml water, shake well, measure 50 ml, put it in a water bath to evaporate, add the right amount of water at any time and evaporate until the solution is almost colorless. Add water to 40ml and check the sulfuric acid according to the inspection method (Appendix ⅧB). If it is cloudy, the standard potassium sulfate solution of 3.75 ml should not be thicker than the control solution (0.01%).
5) Chloroethanol:
Take an appropriate amount of chloroethanol, accurately weigh it, add n-hexane to dissolve it, and dilute it quantitatively to a solution of about 22°g per ml; accurately measure 2ml, place it in a separation funnel containing 24ml n-hexane, add 2ml purified water, and shake well For extraction, take the aqueous solution as the control solution. Another appropriate amount of capsule, cut into pieces, weighing 2.5g, placed in an Erlenmeyer flask stopper, add 25ml of n-hexane, soak overnight, the n-hexane solution is transferred to the separatory funnel, 2ml of water It is added, and the solution is to extract shaking, aqueous solution as an example solution.
6) Check through gas chromatography (Appendix ⅤE):
Use 15% polyethylene glycol-1500 (or 10% polyethylene glycol-20 meters) column length of 2 meters and measure 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 (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. The weight loss range is 12.5% ~ 17.5%.
8) Residue on ignition:
Take 1.0 gram of product and inspect according to law (Appendix ⅧN). The remaining residue (transparent) shall not exceed 2.0%, 3.0% in one part (translucent or transparent and opaque part), 4.0% (in one part translucent and opaque other part) and 5.0% (other opaque part) ).
9) Heavy metals:
The remaining residue is burned and inspected according to the law (Appendix ⅧH, Method 2). The content of heavy metals must not exceed 50 ppm.
10) Viscosity:
Take 4.50g of this product, place it in a 100ml beaker, fix the weight, add 20ml of warm water, and place it in a 60℃ water bath with stirring to dissolve. Take out the beaker, dry the outer wall, and add water to make the total weight of the glue reach the weight of the following calculation formula (including 15.0% dry product). Stir the glue evenly and pour it into a dry Erlenmeyer flask with a stopper. Tighten the stopper and place it in a water bath at 40°C and 0.1°C. After about 10 minutes, put it into a flat viscometer. According to the viscosity measurement method (Appendix g, method 1, capillary inner diameter 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 weight of glue (g) = 15.0
