One solvent name is not a process map
A declaration such as “water extracted” answers only part of a process question. EMA asks for the nature and concentration of extraction solvents and distinguishes the genuine extract from added excipients within its medicinal-product framework.[1] For a buyer review, request a stage-by-stage summary rather than assuming the initial extraction medium describes every subsequent treatment. A general botanical name cannot fill that information gap.
Separate three roles
Use three columns in the sourcing brief: extraction medium, downstream separation or purification medium, and liquid formulation vehicle. Record a declared absence as a supplier statement that needs a defined scope, not as an analytical result. Ask where each medium is introduced and whether it is intended to remain. Keep the final carrier declaration separate from the solvent-removal discussion so that neither is accidentally omitted.
Do not infer selectivity from the plant name
The extraction review identifies solvent properties, particle size, solvent-to-solid ratio, temperature and duration as factors affecting extraction efficiency.[3] Ask for a meaningful process range or approved summary that permits comparison without demanding confidential recipes. If a purification stage changes, compare relevant composition and performance rather than treating an unchanged starting plant as proof that the output remains equivalent.
Translate the map into a solvent question
ICH Q3C addresses organic volatile chemicals used or produced in pharmaceutical manufacture and purification; its testing discussion is linked to process knowledge.[2] This does not make its pharmaceutical limits universal food limits. Ask the supplier and laboratory to justify the relevant analyte list against the disclosed route and intended market. A routine panel name is not enough to show that every relevant solvent has been considered.
Supplier checklist: identify, locate, reconcile
Check that each process-stage declaration identifies the SKU, revision and responsible issuer. Ask which solvent concentrations refer to the extraction mixture and which refer to residual content in the finished material. Reconcile the process summary with the specification and batch report. Escalate contradictions before comparing price or accepting a replacement: “ethanol extraction” and a residual ethanol result describe different quantities.
Decision boundary
Use the completed map to decide what remains unknown, not to award a generic “clean” label. Approval of a solvent for a particular use, evidence of removal, and suitability of the final ingredient are separate decisions. Retain unresolved items in the sourcing record and request product-specific review. No solvent panel, manufacturing route, in-house equipment or market eligibility for a ZL product is asserted here.