Empty Capsule Inspection
Tightness Take 10 capsules of this product, gently pinch both ends of the capsule with your thumb and forefinger, rotate and pull out, and there should be no sticking, deformation or cracking, and then fill with talcum powder, fit the cap and body together, one by one at a height of 1m Drop it straight on a wooden board with a thickness of 2cm, and there should be no leakage of powder; if there is a small amount of leakage, no more than 2 particles. If it exceeds, another 10 tablets should be taken for re-testing, all of which should meet the requirements.
Fragility: Take 50 tablets of this product, place them in a watch glass, transfer them into a desiccator containing a saturated solution of magnesium nitrate, and place them at 25℃±1℃ for 24 hours. 2cm) in the glass tube (inner diameter of 24nm, length of 200nm), the cylindrical weight (material is PTFE, diameter 22mm, weight 20g ± 0.1g) freely fall from the glass tube mouth, depending on the capsule Whether it is cracked, if there is crack, no more than 15 grains.
Disintegration time limit: Take 6 capsules of this product, fill them with talcum powder, and check according to the method of disintegration time limit inspection (Appendix ⅩA) and the method under capsules. All the capsules should melt or disintegrate within 10 minutes. If one pellet cannot be completely melted or disintegrated, another 6 pellets should be taken for re-testing, and all of them should meet the requirements.
Sulfite (as SO<[2]>): Take 5.0g of this product, put it in a long-necked round bottom flask, heat 100ml of water to melt, add 2ml of phosphoric acid and 0.5g of sodium bicarbonate, immediately connect the condenser to 15ml of 0.1mol/L iodine solution is the receiving solution, collect 50ml of distillate, add water to 100ml, shake well, measure 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, according to Sulfate inspection method (Appendix Ⅷ B) inspection, if it is turbid, compared with the control solution made of standard potassium sulfate solution 3.75ml, it should not be more concentrated (0.01%).
Chloroethanol: Take an appropriate amount of chloroethanol, accurately weigh, add n-hexane to dissolve and quantitatively dilute to a solution containing about 22μg per 1ml; accurately measure 2ml, place it in a separatory funnel containing 24ml n-hexane, and add 2ml of water accurately. Shake to extract, and take the aqueous solution as a control solution. Take another appropriate amount of capsules, cut into pieces, weigh 2.5g, put in a stoppered Erlenmeyer flask, add 25ml of n-hexane, soak overnight, transfer the n-hexane solution to a separatory funnel, precisely add 2ml of water, shake to extract, and take the aqueous solution As the test solution.
Check according to gas chromatography (Appendix V E): use a 15% polyethylene glycol-1500 (or 10% polyethylene glycol-20M) column with a column length of 2M, and measure at a column temperature of 110°C. The peak area or peak height of the chloroethanol in the test solution must not exceed the peak area or peak height of the control solution (this is applicable to the ethylene oxide sterilization process).
Loss on drying: Take 1.0g of this product, separate the cap and body, and dry at 105°C for 6 hours. The weight loss should be 12.5% to 17.5%.
Residue on ignition: Take 1.0g of this product and inspect according to the law (Appendix Ⅷ N). The remaining residue shall not exceed 2.0% (transparent), 3.0% (translucent or one section is transparent, the other section is opaque), 4.0% (one section) Translucent, the other section is opaque), 5.0% (opaque).
Heavy metal: Take the residue left under the item of residue on ignition and inspect it according to law (Appendix Ⅷ H Method 2), and the content of heavy metal shall not exceed 50 parts per million.
Viscosity: Take 4.50g of this product, put it in a weighed 100ml beaker, add 20ml of warm water, and stir in a 60℃ water bath to melt. Take out the beaker, dry the outer wall, add water to make the total weight of the glue reach the weight of the following calculation formula (including 15.0% of the dry product), stir the glue and pour it into a dry conical flask with stopper, tightly stopper, and place at 40℃ In a water bath of ±0.1℃, after about 10 minutes, move to the Pingshi viscometer, according to the viscosity measurement method (Appendix VI G first method, capillary inner diameter is 2.0mm), measured in a water bath of 40℃±0.1℃, this product The kinematic viscosity shall not be lower than 60mm<2>/s.
(1－Loss on drying)×4.50×100 total weight of glue (g)=──15.0
