The quality of the capsules should meet the requirements for capsules under the Pharmacopoeia General Rules for Preparation:
1. Appearance: The appearance of the capsule should be neat and tidy, and there should be no bonding, deformation or cracking, and there should be no odor. The contents of the hard capsule should be dry, elastic, and evenly mixed. The capsule contents, regardless of their active ingredients or excipients, should not cause deterioration of the capsule shell.
2. Moisture: The moisture content of the capsule contents shall not exceed 9.0% unless otherwise specified.
3. Difference in loading: When comparing the volume of each capsule with the average loading, the capsules exceeding the limit of the loading difference shall not exceed 2 capsules. If the average loading is 0.30 g or less, the loading difference limit is ±10%; if it is 0.30 g or 0.30 g or more, the loading difference limit is ±7.5%.
4. Disintegration time limit and dissolution: Capsules as a solid preparation usually have to be tested for disintegration time, dissolution or release. Unless otherwise specified, the capsules should meet the requirements. For capsules that require dissolution or release, the time limit for disintegration is not checked.
As for the storage of capsules, visit the article Storage of Empty Capsules for more information.
