Free tool · Molgenium
The Monograph Desk
Paste your drug substance specification. The Desk reads it, works out your ICH Q3A impurity thresholds from the daily dose, checks any elemental limits against ICH Q3D, and tells you what is missing or inconsistent before a regulator finds it.
Your specification never leaves your browser. There is no upload, no account
and no server: every check below is computed on your own machine from the text you paste.
What this checks, and what it does not. The Desk applies the published ICH guidelines:
Q3A/Q3B impurity thresholds and Q3D elemental limits. It holds no pharmacopoeia content, so it will
never tell you what Ph. Eur., USP-NF, JP or BP require — those questions go to a Molgenium
expert, who works from the official texts. It supports your judgement; it does not replace it.
Your specification
Paste the specification table or certificate of analysis as plain text, one test per
line, with the test name and its limit. The Desk understands formats like
Assay: 99.0 - 101.0 %, Any unspecified impurity: NMT 0.10 % and
Lead: NMT 0.5 ppm.
mg per day — sets your ICH thresholds
Impurities, or degradation products