Home / Specification
Specification
What we will publish, and what we have not published yet
A certificate of analysis is the only thing that separates a stated strength from a claimed one. Here is the specification every batch will be tested against, written down before there is a batch to test.
No batch has been released
We have not manufactured a released batch, so there is no certificate to show you. Publishing a mocked-up one would defeat the point of the exercise. What follows is the specification we intend to hold batches to. When the first batch is released, its certificate is published here and travels with the jar.
Release specification
Every figure below is a limit a batch has to meet before it ships. If a batch misses one, it does not ship.
| Test | Method | Specification |
|---|---|---|
| Identity of active | HPLC, retention time vs reference standard | Conforms |
| Assay of clascoterone | HPLC | 95.0 to 105.0% of label |
| Label strength | Calculated | 75 mg/g (7.5% w/w) |
| Appearance | Visual | Off-white, uniform cream |
| Fill weight | Gravimetric | Not less than 30 g |
| Microbial limits | Ph. Eur. 2.6.12 / 2.6.13 | Within non-sterile topical limits |
| Container closure | Visual | Opaque jar, intact seal |
This is a draft specification pending confirmation with the manufacturing partner. It will be republished, with the date it was fixed, before the first batch is released.
What the certificate will carry
Batch number
The number printed on your jar, so the document and the product can be matched.
Measured assay
The actual figure for that batch, not the target. A result of 97.4% is reported as 97.4%.
Dates and signature
Manufacture date, release date, retest date, and who released it.
Questions about the document
Because it is the part that can be checked later. Writing the limits down before there is a result to report means we can be held to them.
A failing batch does not ship, so there is nothing to publish. If a released batch is later found to be out of specification, we will say so here and contact everyone who received it.
Yes. Once a batch exists, its certificate is on this page before anyone is asked to pay for anything.
Testing is done by the manufacturing partner against the specification above. We will name the facility and the analytical lab on the first published certificate.