An excipient compatibility study is the pre-formulation binary (and ternary) screen that combines each candidate excipient with the active at exaggerated stress (40°C/75% RH closed and open, 4 weeks) and measures assay loss, degradant growth, colour change and moisture pickup. The output ranks excipient choices before pilot batches and prevents the most common late-stage stability failures in supplements (mineral–vitamin interaction, hygroscopic blend caking, lipid oxidation in fish-oil softgels).

Regulatory anchors

ICH Q1A(R2)

How V5 handles it

QMS — quality engineered into every action, not bolted on.

Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

Related terms

Supplement Stability Shelf Life