RouteGuard
Where in this process does an amine meet a nitrosating agent, and what forms?
A route-derived nitrosamine screen. Valsartan has no nitrosatable nitrogen and was still recalled worldwide, because the nitrosamine formed in the process. RouteGuard reads your route step by step and tells you where an amine source meets a nitrosating agent, under what conditions, and whether formation happens after your last purification.
The route as you describe it: steps, reagents, solvents, temperatures and isolation points (CSV or JSON).
Could this route make a nitrosamine, in which step, and is there a purge after it?
Free automated sample
Screen one route free and see its overall risk index and which steps are flagged.
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Reviewed packs
RouteGuard Route Screen
2-3 days
- ✓Step-by-step risk register: amine source x nitrosating agent x conditions
- ✓Predicted N-nitroso structures, carryover and solvent-recycle flags
- ✓Formation-after-last-purification test and purge reasoning
- ✓Reviewed by a chemist before delivery
RouteGuard + Control-Strategy Memo
2-3 days
- ✓Everything in the Route Screen
- ✓A written control-strategy memo: which steps to change, test or justify, and why
3-Route Comparison
3-5 days
- ✓Route Screens on three candidate routes, side by side
- ✓A ranked recommendation for route selection on nitrosamine risk
Nitrosamine Complete
3-4 days
- ✓Impurity & Nitrosamine Risk Pack on the final API (structure-derived risk)
- ✓RouteGuard Route Screen on its synthesis (process-derived risk)
- ✓Structure and process covered together, in one reviewed delivery
Pay by card or PayPal, or UPI and Indian cards via Razorpay. Need volume pricing or a white-label arrangement for your own clients? Email support@thechemsolver.com.
What is not included
- ·No relief sizing, HAZOP or regulatory sign-off
- ·No limits or acceptable intakes
- ·Purge reasoning is a prioritisation heuristic, not a purge factor calculation
Frequently asked
Why do I need a route screen if my API has no secondary amine?
Because the nitrosamine does not have to come from your API. Valsartan has no nitrosatable nitrogen; NDMA formed from DMF breakdown meeting sodium nitrite in the tetrazole step. A structure-only screen cannot see that, a route screen can.
What format should the route be in?
A simple CSV with one row per step (step, name, reagents, solvents, temp_c, isolates) is enough, or JSON. For a reviewed order you can also describe it in your own words and we will build the route file with you.