Extractables & Leachables Study Report

1. What this module does

You enter the route, the units per day and the uncertainty factor. The tool calculates the AET from the safety concern threshold (0.15 µg/day for inhalation, 1.5 µg/day otherwise, or your own).

It flags extractables at or above the AET that are not identified or assessed, and compares each leachable's daily exposure with its PDE, or with the TTC when it has a mutagenic alert.

What you get

• A Word or PDF report: Extractables and leachables study report.

2. Before you start

Have these ready. You can still start with the example data and replace it piece by piece.

• The components, materials and extraction conditions.
• Extractables with levels, identification and PDEs.
• Leachables results on stability.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/extractables-leachables.html. The example is loaded when the page opens, so every panel already has realistic data. Follow the steps to see how it works, then replace the example with your own data.

1. Describe the product

   Choose the route and treatment duration, and enter the units per day and the uncertainty factor.

   

2. Enter extractables and leachables

   One row per extractable and component, and one row per leachable result. Put a name that contains a comma in quotes.

3. Read the result

   The headline gives the outcome: "3 leachables · all below the permitted exposure".

   

4. Resolve alerts and download

   A leachable above its limit is critical. Extractables above the AET without identification or assessment, and leachables not seen as extractables, are flagged. Then preview and download.

   

4. Field reference

Every input in the tool, panel by panel. Tables accept rows pasted straight from Excel, comma-separated text, or a loaded file; check the columns after loading a file. Fields marked “when it applies” appear only for the choices that need them.

1 · Product and dosing

2 · Components and extraction study

3 · Extractables

One row per compound and component. Level in µg per unit (syringe).

4 · Leachables

Results from the drug product on stability (simulation or real-time). Level in µg per unit.

5. Checks and alerts

Calculations and pass/fail outcomes always come from fixed rules, never from AI. The tool checks:

• AET from the SCT, dosing and uncertainty factor.
• Identification and safety assessment above the AET.
• Leachable exposure against PDE or TTC; correlation with extractables.

How to resolve alerts

• Critical alerts block the download and must be fixed in the data. A failing result can instead be linked to an investigation: type the investigation reference and outcome and press Record.
• Major alerts block the download until you fix them or type a justification and press Accept justification.
• Minor alerts do not block anything. They are listed in the documents so the reviewer sees them.
• Some alerts have an Apply fix button that makes the change for you. Reopen undoes a justification.

Narratives

This module writes: Discussion and conclusion. Each narrative is written by fixed rules from your data. You can edit it in the box. Rewrite with AI (where your plan includes AI) rewrites it in regulatory style; every number in the text is checked against your data, and a number that does not match is flagged under the box and blocks the download until you correct it. Reset to rule-based text brings back the original.

6. Preview, gap review and download

1. Press Preview next to a section, or Preview and download all. The document opens in a preview window, exactly as the Word file will read.
2. The left side lists the review, run on your device: gaps in the data (missing values, open alerts), gaps in the report (missing content the guidance expects, placeholders such as [site] or TBD left in the text) and, if you load the approved protocol under Compare with the protocol, differences from the protocol (requirements, criteria, batches or time points it plans that the report does not show).
3. Click a finding to jump to the place in the preview. Fix it in the tool, then preview again.
4. Optional AI review: a second read for contradictions, claims without data and vague wording. The report text is sent to Claude only when you press it, and only where your plan includes AI. Check every AI finding; AI can be wrong.
5. Press Download Word (.docx) or Download PDF. With several documents open, All as Word (.zip) and All as PDF (.zip) download the set. The download buttons stay disabled while a blocking alert is open; the preview still works.

Documents this module produces

Use Save project to keep your work as a file on your computer, and Open project to continue later. Start blank clears every field; Load example brings the example back. Nothing is stored on CMCfy servers.

7. US and EU submissions

US follows USP <1663>/<1664> and the FDA container closure guidance (1999). EU follows the EMA guideline on plastic immediate packaging materials.

8. Working with other modules

• The container closure section (3.2.P.7) is written in the Container Closure & E&L.

9. Common pitfalls

• Tentative identities left unconfirmed above the AET.
• No leachables data at the end of shelf life.

10. Practice exercises

Each exercise starts from the example (press Load example to reset). We run these on every update of this guide, so the result you see should match.

1. Raise a leachable

   Change the 6-month 25 °C result for 2,4-di-tert-butylphenol from 0.61 to 2000 µg/unit.

   Expected resultThe headline shows one leachable above the permitted exposure.