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Capsule Pharmaceutical Inspection
Jul 01, 2017

             Tightness: Take this product 10 tablets, with thumb and index finger lightly pinch capsule at both ends, the rotation pulls out, may not have the bond, the distortion or the rupture, then fills the talcum powder, will cap, the body sleeve, by the grain in the 1m height to fall directly in the thickness to the 2cm plank, should not leak the powder, if has the small leakage powder, may not surpass 2 tablets. If more than, should take another 10-second retest, should be in accordance with the provisions.

             Brittleness: Take this product 50 tablets, place the surface dish, move into the dryer with magnesium nitrate saturated, place the 25 thermostat for 24 hours, remove, immediately separate into the glass tube upright in the plank (thickness 2cm) on the inside diameter of 24nm, length 200nm), the cylindrical weight (material for PTFE, diameter of 22mm, heavy 20.1g) from the glass tube at the mouth of the free fall, depending on whether the capsule rupture, if there is rupture, not more than 15 tablets.

              Disintegration time: Take 6 tablets of this product, filled with talcum powder, according to disintegration time check method (Appendix Sua), capsule under the method of inspection, each grain should be dissolved or disintegrating in 10 minutes. If 1 grains can not dissolve or disintegrate all, should take another 6-second retest, should be in line with the provisions.

               Sulfite (With so <[2]>): Take this product 5.0g, put the long neck round bottom flask, heating water 100ml to dissolve, add phosphoric acid 2ml and sodium bicarbonate 0.5g, instant connection to the condenser tube, to 0.1mol L Iodine solution 15ml to receive liquid, collect distillate liquid 50ml, add water to 100ml, shake evenly, take 50ml, place water bath evaporation, at any time to replenish the amount of water, steaming to the solution almost colorless, add water to 40ml, according to the sulfate Inspection method (appendix Bib) Check , such as turbidity, compared with the standard potassium sulfate solution 7.5ml, the contrast liquid is not thicker (0.02%).

                Chlorine ethanol: The right amount of chlorine ethanol, precision weighing, plus hexane dissolved and quantitatively diluted into each 1ml of the solution containing 22, the precise amount of 2ml, set Sheng has a positive hexane 24ml in the liquid funnel, precision add water 2ml, shake extraction, take water solution as a control solution. Another to take the appropriate amount of capsules, cut, weighing 2.5g, placed in a cone-shaped bottle, plus hexane 25ml, dipping overnight, will be hexane liquid into the liquid funnel, precision add water 2ml, vibration extraction, take water solution as a test solution. According to the gas Chromatographic method (Appendix Shine), 15% polyethylene glycol-1500 (or 10% polyethylene glycol 120m) column, column length 2M, was measured under the column temperature 110 Shan. The peak area or peak height of chlorine ethanol in the solution can not exceed the peak area or peak height of the control solution (this is suitable for the ethylene oxide sterilization process).

                Weight loss: Take this product 1.0g, the CAP, body separately, in 105 Shan drying 6 hours, loss weight should be 12.5% ~ 17.5%.Capsule

Burning residue to take this product 1.0g, according to the Law Inspection (appendix Shan), the residual residue shall not be 2% (transparent), 3% (translucent or transparent, another section opaque), 4% (one translucent, another section opaque), 5% (opaque).Capsule

              Heavy metals: The residue remaining under the ignition residue is inspected according to law (appendix Shanh Second Law), containing heavy metals not to exceed fifty out of 10,000.

               Viscosity: Take this product 4.50g, set the weight of the 100ml beaker, heating water 20ml, place 60 Shan water bath stirring, so that dissolve. Remove the beaker, dry the outer wall, add water to the total weight of the glue to achieve the following calculation of the weight (including dry product 15%), stir-fry the glue and pour into the dry cone-shaped bottle, dense plug, 40.1 water bath, about 10 minutes later, moved to the flat viscosity meter, according to the Viscosity Determination method (appendix Shang The first method, the capillary diameter of 2.0mm), in 40.1 Water bath determination, the product movement viscosity should not be less than 60mm <2>/s.Capsule


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