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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 120 | Result | OK? |
| Average Fill Weight | 0,6% from target weight | ✔ |
| % of capsules within ± 3% of target weight | 96% | N/A |
| % of capsules within ± 7% of target weight | 100% | N/A |
| % of capsules within ± 10% of target weight | 100% | ✔ |
| Full Metal 400 | Result | OK? |
| Average Fill Weight | 0,7% from target weight | ✔ |
| % of capsules within ± 3% of target weight | 82% | N/A |
| % of capsules within ± 7% of target weight | 100% | N/A |
| % of capsules within ± 10% of target weight | 100% | ✔ |
Conclusions
The capsule fillers tested allow to meet the EP and USP “Uniformity of Dosage Units” acceptance limits.
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