Oral solid testing established to USP <711> and <905>
Ergopharm has established dissolution testing to USP <711> and uniformity of dosage units to USP <905> as release tests for its oral solid-dose products.
A tablet that contains the right amount of active substance has met only half the requirement. If it does not release that substance at a rate the body can absorb, the content is irrelevant — which is what dissolution testing measures, and why it is the test that most distinguishes a controlled oral product from a compressed powder.
“The patient takes one tablet, not the batch average.”
Method development sets the apparatus, medium, volume, agitation rate and sampling times, with sink conditions confirmed and the method shown to discriminate between acceptable product and product deliberately made outside the process range. A method that passes everything discriminates nothing.
Uniformity of dosage units under <905> confirms that the content of individual units, not merely the batch average, sits within limits — the measure that matters to the patient taking one tablet rather than the whole batch.
Key facts
- Chapters
- USP <711> dissolution; USP <905> uniformity of dosage units
- Method must
- Discriminate between in-range and out-of-range product
- Confirmed
- Sink conditions, agitation, sampling times
- Uniformity
- Individual units assessed, not only batch average
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.