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Check after capsule filling

Views:0     Author:Site Editor     Publish Time: 2020-11-20      Origin:Site

Check after capsule filling

Take the capsule of 10 products, gently pinch the two ends of the capsule with thumb and forefinger, rotate the capsule away without any bond, deformation or rupture, and then put talc powder into it. The cap and the capsule are closed, one after the other, and drop vertically on the 2cm thick plate at a height of 1 meter, and the powder should not leak. A small amount of powder shall not exceed 2 particles. If this limit is exceeded, an additional 10 capsules should be collected for new testing, all of which should meet the requirements.

A plate of 50 capsules on vessel, into the dry container containing magnesium nitrate solution, to a constant temperature for 24 hours, remove and immediately, respectively, the vertical grain on the wood grain (2 cm) of glass tube, the weight of the cylindrical weight (ptfe material, 22 mm in diameter, about 20 g weight) from the glass tube mouth free fall, whether capsule rupture, such as fracture should not exceed 15 grains.

Disintegration time: Take 6 tablets of this product, fill them with talc powder, conduct the test procedure of disintegration time and the capsule diagnosis method, and melt or fall off within 10 minutes. If one does not fully dissolve or decompose, collect another six grains for a new test, all of which meet the requirements.

Sulfite take 5 shells, the product in a long neck, round bottom flask is heated, 100 ml water dissolved in phosphoric acid and sodium bicarbonate, instantaneous compression connection condenser pipe, iodine solution as a liquid, add 50 ml of distillate and 100 ml water, mix, take 50 ml dose, bathroom water evaporation, add water at any time, to the solution almost colorless, with 40 ml of steam and water, like sulfuric acid test program to check, such as turbidity, compared with the standard potassium solution, shall not be thicker.

Chloroethyl alcohol: take an appropriate amount of chloroethyl alcohol, weigh it accurately, dissolve it with hexane, and dilute it quantitatively in the solution; Weigh an appropriate amount of 2mL, put it into a 24ml n-hexane separation funnel, add an appropriate amount of 2mL water, shake well, and extract the aqueous solution as the control solution. An appropriate amount of the capsule was taken, cut into pieces, and 2.5 grams were taken, placed in a conical cork, and 25ml n-hexane was added to soak overnight. The transferred n-hexane solution was diluted into a funnel, and 2ml water was added, and the free aqueous solution was taken out as the test solution.

Dry weight loss :1 g product, separated cap and body, drying at 105℃ for 6 hours, weight loss must be about 12-17.

Heavy metal: waste incineration legacy, should be checked, containing no more than 50 parts per million of heavy metal.

Viscosity: 4.5 grams of product, fixed weight bottle 100 ml, 20 ml warm water, stir to dissolve the damage. After removing the beaker and drying the water wall, the emulsion is stirred in the flask and dried for about 10 minutes. Then it is moved to the viscometer and capillary viscometer. The viscosity of the product shall not be lower than 60mm/s.

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