Fill Weight Tests

Specifications

The practitioner should refer to the regulations to which he is subject. The European Pharmacopeia (EP) and United States Pharmacopeia (USP), for example, describe detailed methods of quality control for compounding preparations with hard capsules. For more detailed information, please refer to USP 795 (Pharmaceutical Compounding – Nonsterile Preparations) and USP 1163 (Quality Assurance in Pharmaceutical Compounding). The following specifications, that we follow for our tests, ensure that we comply with the USP and EP:
  • The fill weight of each individual capsule must be within 10% of the target fill weight.
  • The average fill weight must be within 3% of the target fill weight.

Procedure

The following tests were performed on the Universal (120 capsules) and the Full Metal (400 capsules) fillers respectively. The capsule size used was size 1. All capsules were weighed individually.

Results

Universal 120ResultOK?
Average Fill Weight0,6% from target weight
% of capsules within ± 3% of target weight96%N/A
% of capsules within ± 7% of target weight100%N/A
% of capsules within ± 10% of target weight100%
Full Metal 400ResultOK?
Average Fill Weight0,7% from target weight
% of capsules within ± 3% of target weight82%N/A
% of capsules within ± 7% of target weight100%N/A
% of capsules within ± 10% of target weight100%

Conclusions

The capsule fillers tested allow to meet the EP and USP “Uniformity of Dosage Units” acceptance limits.

Feton Headquarters:
Feton International sprl
Rue de la Croix du Maïeur 8
7110 Strépy-Bracquegnies, Belgium
Feton International Logo

We use cookies to operate this website and to improve its usability. Please note that by using this site you are consenting to the use of cookies.