Lifecycle Assist Pro – 1-year License

Lifecycle Assist Pro™ — 1-year licence

From molecule to method, validation and shelf life, in one connected workflow.

Most stability-indicating methods are designed before anyone knows what the degradants look like. Then forced degradation finds a peak under the API, and the method goes back to development.

Lifecycle Assist Pro reverses the order. Enter the structure once, and every stage builds on the one before it. The pKa values set the pH window, the chemical liabilities predict the degradants, and the degradants are placed on your chromatogram before you choose the method.

Eight connected stages

1. Molecule: pKa (published PubChem values when online), log D across pH, UV and MS advice, chemical liabilities, CPCA nitrosamine risk, and a 3D structure view.
2. Analytical Target Profile: ICH Q3A/Q3B reporting, identification and qualification thresholds from your daily dose, plus the ICH Q2(R2) characteristics your method will need.
3. HPLC method: a designer that screens about 2,500 methods and stress-tests the best 40. It calibrates to your own column from two scouting injections and transfers methods to UHPLC by USP <621>.
4. Forced degradation: a stress protocol for every arm, with degradant structures placed on your method and a stability-indicating verdict. Isobaric species, the ones MS cannot see, are flagged.
5. Robustness: a design-space map (MODR), the ICH Q2(R2) deliberate variations, and system suitability limits derived from the worst case.
6. Validation: ICH Q2(R2) statistics on your own data, with every criterion shown.
7. Shelf life: ICH Q1A(R2) study design, ASAP humidity-corrected Arrhenius with packaging curves, and ICH Q1E regression with batch poolability.
8. Report: a formal analytical development report, as a PDF or an editable Word file.

Try it before you buy

The free demo runs four worked molecules (Amlodipine, Losartan, Omeprazole and Ibuprofen) through all eight stages, with no key needed:

https://lifecycle-assist-pro.vercel.app

What you get

• A one-year licence key that unlocks your own molecules, project import and report export
• Use on two devices, one at a time
• Runs in any browser: Chrome, Edge, Firefox or Safari. Nothing to install
• The Professional User Guide (18 pages, Word) and the Welcome & Access sheet
• Your projects stay in your own browser and are never uploaded

Who it is for

Analytical chemists in method development, QC, stability and CMC, and anyone teaching or learning how a stability-indicating method is built.

Scope, stated plainly

Lifecycle Assist Pro is a scientific decision-support and teaching tool. Its predictions are models, not measured results. It is not a validated computerised system and does not create a GxP record. Confirm every method experimentally on your own instrument.

Expand Your Learning:

• YouTube Channel: Watch step-by-step educational videos at YouTube/@PracticalPharmaScience.
• Practical Pharma Science Website: Visit practicalpharmascience.com to access 20+ FREE practical HPLC & LC-MS tools. Plus, check out the Chromie Academy web application for free interactive courses!

Mirela Gorjanu — Practical Pharma Science™