Ten matters needing attention in purchasing hollow capsules
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 adhesion, deformation and rupture, then fill it with talc powder, cover the bottle cap and bottle body, and drop the capsule piece by piece on a 2cm thick and 1m high wood board without powder leakage. If a small amount of powder is leaked, it shall not exceed 2 tablets. If more than 10 times, you should take another 10 retests and abide by the regulations.
2. Fragility:
Take 50 pieces of this product, put them in glasses, move them to a dryer filled with saturated magnesium nitrate solution, and keep them at 25 ℃ 1 ℃ for 24 hours. After taking them out, immediately put them one by one into a glass tube standing on a wooden board (thickness 2cm), and put the cylindrical weight (made of polytetrafluoroethylene, diameter 22mm, weight 20g ± 0.1g) down freely from the glass tube mouth. According to whether the capsule is broken, if any, No more than 15 pieces.
3. Disassembly time limit:
Take 6 products, fill them with talc powder, and check the inspection methods and methods in the capsule according to the disassembly time limit. Each tablet should be completely dissolved or disintegrated within 10 minutes. If one tablet cannot be completely dissolved or disintegrated, take another 6 tablets for reexamination, and the reexamination shall meet the requirements.
4. Sulfite:
Instead of 5.0 g of product, heat and dissolve 100 ml of water in a long neck round bottom flask, add 2 ml of phosphoric acid and 0.5 g of sodium bicarbonate, immediately connect the condenser tube, take 15 ml of 0.1 mol / L iodine solution as the receiving solution, collect 50 ml of fraction, add 100 ml of water, shake well, measure 50 ml, put it in a water bath for evaporation, add an appropriate amount of water and evaporate at any time, Until the solution is almost colorless. Add water to 40 ml and check sulfuric acid according to the inspection method. If it is cloudy, do not use 3.75 ml of standard potassium sulfate solution thicker than the control solution (0.01%).
5. Chloroethanol:
Take an appropriate amount of chloroethanol, weigh it accurately, add n-hexane to dissolve it, and quantitatively dilute it to about 22 ° g per ml; Accurately measure 2ml, put it into the separation funnel containing 24ml n-hexane, add 2ml refined water, shake well and extract, and take the aqueous solution as the control solution. Another appropriate amount of capsule, cut into pieces, weighing 2.5G, placed in a conical bottle stopper, plus 25ml of n-hexane, soaked overnight, the n-hexane solution was transferred to the separating funnel, 2ml of water was added, and the solution was extracted and shaken, and the aqueous solution was used as an example solution.
6. Check by gas chromatography:
Use 15% polyethylene glycol-1500 (or 10% polyethylene glycol-20m) column with a length of 2M and measure at a column temperature of 110 ℃. 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 ethylene oxide sterilization process).
7. Drying loss:
Take 1.0g of this product, separate the bottle cap from the bottle body, and dry at 105 ℃ for 6 hours. The weight loss range is 12.5% - 17.5%.
8. Ignition residue:
Take 1.0 g of product and check it according to law. The remaining residue (transparent) shall not exceed 2.0%, 3.0% in one part (translucent or transparent and opaque parts), 4.0% (in other parts of one part) and 5.0% (other opaque parts).
9. Heavy metals:
The residue left shall be burned and inspected according to law (Appendix VIII h, method 2). The content of heavy metals shall not exceed 50ppm.
10. Viscosity:
Take 4.50g of this product, place it in a 100ml beaker, fix the weight, add 20ml of warm water, and put it in a 60 ℃ water bath to stir and dissolve. Take out the beaker, dry the outer wall, add water to make the total weight of the glue liquid reach the weight of the following calculation formula (including 15.0% dry product). After stirring the glue evenly, pour it into a dry conical bottle with a stopper, tighten the stopper, place it in a 40 ℃ 0.1 ℃ water bath, and put it into a flat viscometer after about 10 minutes. According to the viscosity measurement method (method 1, capillary inner diameter 2.0mm), the kinematic viscosity of the product measured in a water bath at 40 ℃ 0.1 ℃ shall not be less than 60mm < 2 > / s. (1 drying loss) × four point five zero × Total weight of 100 glue solution (g) = - 15.0
