The Empty capsules are becoming more and more popular. First of all, the capsules are slender in shape and easy to swallow, which is the most popular dosage form for consumers; in addition, capsules can effectively mask the unpleasant taste and odor of the contents. Capsules come in a variety of sizes, including size 00 extended and size 5 capsules. Capsules can also be printed with text, logos and graphics for a unique custom look.
Today we will talk about the inspection of empty capsules:
- Tightness: Take 10 capsules of this product, gently pinch both ends of the capsule with your thumb and forefinger, rotate to pull out, there should be no adhesion, deformation or rupture, then fill with talcum powder, fit the cap and body, and place the capsules one by one. If it falls directly on a wooden board with a thickness of 2cm from a height of 1m, no powder should leak; if there is a small amount of powder leakage, it should not exceed 2 grains. If it exceeds, another 10 capsules should be taken for retest, all of which should meet the requirements.
- Friability: Take 50 grains of this product, put them in a watch glass, put them in a desiccator containing a saturated solution of magnesium nitrate, set them at a constant temperature of 25ā±1ā for 24 hours, take them out, and immediately put them one by one on a wooden board. In the glass tube (with a thickness of 2cm) (inner diameter is 24nm, length is 200nm), a cylindrical weight (material is PTFE, diameter is 22mm, weight 20g±0.1g) is freely dropped from the mouth of the glass tube, Depending on whether the capsules are ruptured, if ruptured, do not exceed 15 capsules.
- Disintegration time limit: Take 6 capsules of this product, fill it with talcum powder, and check according to the disintegration time limit inspection method (Appendix ā
© A) and the method under capsules. Each capsule should be completely dissolved or disintegrated within 10 minutes. . If 1 capsule cannot be completely melted or disintegrated, another 6 capsules should be taken for retest, all of which should meet the requirements.
- 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 it according to the law (Appendix ā
§ N). One section is translucent, the other is opaque), 5.0% (opaque).
- Heavy metals: Take the residue left under the item of residue on ignition and inspect it according to the law (Appendix VIII H second method). The heavy metal content should not exceed 50 parts per million.
- Viscosity: Take 4.50g of this product, put it in a 100ml beaker that has been weighed, add 20ml of warm water, and stir in a 60°C water bath to dissolve. Take out the beaker, wipe the outer wall dry, add water to make the total weight of the glue solution reach the weight of the following formula (including 15.0% of the dry product), stir the glue solution evenly, pour it into a dry stoppered conical flask, seal it tightly, and set it at 40°C In a ±0.1ā water bath, after about 10 minutes, move it to a flat viscometer, and measure it in a water bath at 40ā±0.1ā according to the viscosity measurement method (Appendix VI G first method, the inner diameter of the capillary is 2.0mm). The kinematic viscosity shall not be lower than 60mm<2>/s.
For details, please consult: Custom Capsule Manufacturers.
