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Inspection of hollow capsules
Nov 14, 2016

Tightness take this product 10 capsules, light with your thumb and forefinger pinch both ends of the capsule, rotating out, without bond, deformation or rupture, and then filled with talcum powder, Cap, body cover, grain-by-height straight fall in the thickness of the 1M on the wood of 2cm, shall not be leakage if there is a small amount of leakage shall not exceed 2 tablets. If it exceeds, another 10 grains re-testing, should meet the requirements.

Crisp broken degrees: take this products 50 grain, reset surface dish in the, moved into sheng has nitric acid magnesium saturated solution of dry device within, reset 25 ℃ ± 1 ℃ thermostat 24 hours, out, immediately respectively by grain into erect in wood (thickness 2cm) Shang of glass tube (diameter for 24nm, long for 200nm) within, will cylindrical shaped weight (material for PTFE, diameter for 22mm, and heavy 20G ± 0.1g) from glass tube mouth at free falls, depending on capsule whether rupture, as has rupture, shall not over 15 grain.

Disintegration: take 6 capsules, filled with talcum powder, according to the disintegration test (Appendix a, x), the method checks under the capsule, each grain should be all melted or disintegrated within 10 minutes. If 1 particles that cannot be dissolved or disintegrating, should take another 6 tablets of re-testing, should meet the requirements.

Sulfite (to SO <[2]> meter): take this products 5.0g, reset long neck round end of flask in the, heating water 100ml makes dissolved, added phosphate 2ml and sodium bicarbonate 0.5G, rates connection condensation tube, to 0.1mol/L iodine solution 15ml for received liquid, collection distillation out liquid 50ml, added water to 100ml, shake uniform, volume take 50ml, reset water bath Shang evaporation, at any time added water amount, steam to solution almost colorless, added water to 40ml, as sulfate check method (Appendix ⅷ b) check Such as turbidity, compared with the standard solution of potassium sulfate made of 3.75ml control solution, not more (0.01%).


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