Capsule Storage Conditions
10 Jun 2022
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2. The low dose API should be diluted with an appropriate diluent and mixed evenly.
3. Hard capsules can be prepared according to the following molding techniques and filled into empty capsules of various contents.
(1) Add suitable excipients such as diluents, sliders, disintegrants, etc. to make the raw drug a uniform powder, lump, or small tablet.
(2) Fill ordinary pellets, immediate-release pellets, sustained-release pellets, controlled-release pellets, or enteric-coated pellets individually or in combination, and add an appropriate number of empty pellets as filler if necessary.
(3) Fill the raw drug powder directly.
(4) The raw drug is converted into an inclusion compound, a dispersion solid, a microcapsule or a microsphere.
(5) Solutions, suspensions, emulsions, etc. they can also be filled into empty capsules with a special capsule filling machine and sealed if necessary.
4. Capsules must be clean and tidy and the shell of the capsule must be free of adhesion, deformation, spillage or cracking and odors.
5. The microbial limit of the capsules must meet the requirements.
6. Depending on the characteristics of the raw materials and preparations, with the exception of capsules containing different constituents from animals and plants, it is difficult to develop a method of measurement that requires adherence to solutions, release and uniformity of content. Capsules should be inspected visually for particulate matter.
7. Unless otherwise specified, capsules should be sealed and stored, the temperature of the storage environment should not exceed 30 ℃, and the humidity should be adequate to prevent moisture, mold, and damage. The production and quality control of stock solutions of organic products, semi-finished products and finished products must meet the requirements of the relevant varieties.
1. The contents of the capsule, whether raw or excipient, must not damage the capsule shell.3. Hard capsules can be prepared according to the following molding techniques and filled into empty capsules of various contents.
(1) Add suitable excipients such as diluents, sliders, disintegrants, etc. to make the raw drug a uniform powder, lump, or small tablet.
(2) Fill ordinary pellets, immediate-release pellets, sustained-release pellets, controlled-release pellets, or enteric-coated pellets individually or in combination, and add an appropriate number of empty pellets as filler if necessary.
(3) Fill the raw drug powder directly.
(4) The raw drug is converted into an inclusion compound, a dispersion solid, a microcapsule or a microsphere.
(5) Solutions, suspensions, emulsions, etc. they can also be filled into empty capsules with a special capsule filling machine and sealed if necessary.
4. Capsules must be clean and tidy and the shell of the capsule must be free of adhesion, deformation, spillage or cracking and odors.
5. The microbial limit of the capsules must meet the requirements.
6. Depending on the characteristics of the raw materials and preparations, with the exception of capsules containing different constituents from animals and plants, it is difficult to develop a method of measurement that requires adherence to solutions, release and uniformity of content. Capsules should be inspected visually for particulate matter.
7. Unless otherwise specified, capsules should be sealed and stored, the temperature of the storage environment should not exceed 30 ℃, and the humidity should be adequate to prevent moisture, mold, and damage. The production and quality control of stock solutions of organic products, semi-finished products and finished products must meet the requirements of the relevant varieties.
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