We often see the drug inspection results released by the National Medical Products Administration, and one important indicator of whether the drug inspection is qualified or not is the "weight difference/loading amount difference". The so-called weight difference/loading amount difference refers to the difference between the individual weight of the drug and the average tablet weight of the batch, which cannot exceed a certain limit.

We take capsules as an example to illustrate:

Capsules refer to solid preparations made from raw materials or suitable excipients filled in hollow capsules or sealed in soft capsule materials. They can be divided into hard capsules, soft capsules (capsules), sustained-release capsules, controlled release capsules, and enteric coated capsules, mainly for oral administration.

According to the provisions of the Pharmacopoeia of the People's Republic of China (2020 edition), in the 0103 General Principles for Capsules, it is necessary to check the difference in filling amount. The limit of filling amount difference for capsules is shown in the following figure:

Attachment: The limit of differences in capsule dosage specified in the 2020 edition of the Pharmacopoeia:

Therefore, in order to avoid products being classified as inferior drugs in quality inspection, pharmaceutical companies must conduct testing and control of drug weight or loading throughout the production process.