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 records next to the work they concern.

Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.

Document control — one version in force, every change signed and explained.

Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.

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 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

Excipient compatibility study

Next step

Excipient compatibility study

Next step