Question
Posted on: March 6 2013How does one work best to check the dispersion of mass of prepared capsulation?
What number of gelules should one check per batch by weighting? Is The following rule generally in effect?
- for capsule < 300 mg: Max 2 with 10% deviation and none with more than 20% deviation
- for capsule > 300mg: Max 2 with 7.5% deviation and none with more than 15% deviation
Answer
According to the Pharmacopoeia one weighs a capsule, empts it to weigh the unladen capsule (body + head). The difference between the two masses corresponds to the mass of the capsule. This operation is repeated on 19 capsules. The standards you specify are in accordance with the Pharmacopoeia.
For the Officina this is not a handy method. A method is described in the TMF, which one can apply for a reasonably rapid control in the Officina.