This product has a cylindrical shape and is a hard and elastic empty bag composed of a cap and a body that can be nested and locked. The capsule should be smooth, uniform in color, smooth incision, no deformation, and no odor. This product is divided into three types: transparent (both sections do not contain sunscreen), translucent (only one section contains sunscreen), and opaque (both sections contain sunscreen).
(1) Take 0.25g of this product, add 50ml of water, heat to dissolve, let it cool, shake well, take 5ml of the solution, add a few drops of potassium chromate test solution-dilute hydrochloric acid (4:1) to produce orange-yellow flocculent precipitate .
(2) Take 1ml of the solution under identification (1), add 50ml of water, shake well, add a few drops of tannic acid test solution, and turbidity will occur.
(3) Take about 0.3g of this product, put it in a test tube, add a little soda lime, the gas generated can make the wet red litmus paper turn blue.
【Check】 Disintegration time limit Enteric-coated capsules
take 6 capsules of this product, fill with talc powder, and check according to the method under the disintegration time limit inspection method (Appendix ⅩA) enteric-coated capsules, which should meet the regulations.
Colon enteric-coated capsules Take 6 capsules of this product, fill with talc powder, and check according to the method under the disintegration time limit inspection method (Appendix ⅩA) enteric-coated capsules, which should meet the regulations.
Tightness, sulfites, parabens, chlorohydrin, ethylene oxide, loss on drying, residue on ignition, chromium, heavy metals and microbial limits The method inspections under the lighting glue hollow capsule should all comply with the regulations.
【Category】Pharmaceutical excipients for the preparation of delayed-release capsules.
【Storage】Airtight, temperature 10℃-25℃, relative humidity 35%-65%.