| Botanical identity | Confirm the declared species is Cotinus coggygria Scop. and that the common name “smoke tree” is not being used ambiguously for another plant. | Supplier specification; authenticated reference material; macroscopic or microscopic examination for raw herb; chromatographic fingerprint for the extract. | The Latin binomial and plant part should be consistent across the specification, batch record, label, and certificate of analysis (COA). |
| Plant part and origin | Check which plant part is extracted (for example, leaf, bark, or other stated material), the country of cultivation or collection, and the harvest or sourcing controls. | Raw-material traceability records; supplier declarations; harvest and processing records; risk-based identity testing. | Do not assume results for one plant part apply to another; the part used should match the product’s intended use and applicable rules. |
| Extraction details | Verify the extraction solvent, native extract ratio or drug-extract ratio where applicable, carriers or excipients, and whether the stated extract is native or formulated. | Product specification; manufacturing flow; solvent and carrier declarations; batch records. | Check that ratios and assay values are clearly defined and are not presented in a way that confuses extract with carrier-containing powder. |
| Identity fingerprint and marker assay | Ask how the extract is identified and standardized. If a marker such as a specified polyphenol is declared, confirm the marker, method, calculation basis, and acceptance range. | Validated or suitably verified HPLC/UPLC fingerprint and assay; reference-standard details; representative chromatograms. | There is no single universal marker specification for every smoke tree extract; the method and limits should be product-specific and justified. |
| Heavy metals | Assess lead, cadmium, arsenic, and mercury against the requirements applicable to the destination market and intended product category. | Batch-specific ICP-MS or ICP-OES report from a qualified laboratory; stated methods, units, and reporting limits. | Compare results with the applicable legal or compendial limits; do not treat a generic “pass” statement as a substitute for numeric results. |
| Microbiological quality | Review total aerobic microbial count, total yeast and mold count, and specified pathogens according to intended use and market requirements. | Batch COA with test methods, results, units, and specified-organism findings; methods may reference recognized compendial procedures where appropriate. | Limits depend on the product category and jurisdiction; verify the applicable specification rather than assuming one global limit. |
| Pesticide residues | Confirm that the testing scope reflects the botanical supply chain and the pesticide-residue rules of the importing market. | Risk-based multi-residue analysis, commonly using LC-MS/MS and GC-MS/MS; full analyte list and laboratory report. | For EU-bound products, assess applicable maximum residue levels under Regulation (EC) No 396/2005; confirm current rules for other markets separately. |
| Residual solvents | Check that any extraction or processing solvents are declared and that residual levels are controlled for the intended product and market. | Headspace GC or another suitable validated method; solvent-use statement; batch results when required by risk or specification. | Use the applicable jurisdictional or compendial requirements; ICH Q3C may be a relevant reference where its scope applies. |
| Adulteration and undeclared additives | Check for undeclared carriers, colors, preservatives, synthetic marker addition, or substitution with other botanical materials. | Full ingredient and processing declarations; chromatographic comparison; risk-based targeted testing. | The ingredient list and composition should match the purchase specification and all applicable labeling requirements. |
| Manufacturing controls | Review the quality system, sanitation, process controls, deviation handling, change control, and batch release procedures. | Quality-system documents; audit report; batch manufacturing and packaging records; recall and complaint procedures. | For US dietary supplements, assess applicable requirements under 21 CFR Part 111. Confirm other market-specific GMP obligations separately. |
| Certification scope | If certifications are claimed, verify the issuing body, certificate validity, site address, product or activity scope, and audit status. | Current certificates and, where relevant, audit documentation for systems such as ISO 22000 or a recognized food-safety certification scheme. | A management-system certificate does not by itself prove that a specific batch meets its specification or legal requirements. |
| Batch documentation and traceability | Confirm that each shipment can be linked to a production batch, raw-material lots, manufacturing date, and release decision. | Batch-specific COA; lot-number system; retained-sample policy; traceability and recall records. | The COA should identify the tested batch and include specifications, actual results, units, test methods, and authorized approval. |
| Stability and packaging | Check the basis for shelf life, storage instructions, packaging suitability, and controls against moisture, light, and contamination. | Stability data for the product or a scientifically justified approach; packaging specification; moisture or water-activity data where relevant. | Shelf life and storage conditions should be supported by data and match the product’s actual packaging and distribution conditions. |
| Market authorization and claims | Before import or sale, confirm the ingredient’s permitted status, product-category rules, labeling requirements, and whether proposed claims are lawful. | Regulatory assessment for the destination country; ingredient and label review; supporting evidence for any permitted claims. | Requirements vary by market and intended use; do not assume that a botanical’s sale in one country establishes authorization elsewhere. |