| Identity and chemical authenticity | Confirm that the material is urolithin A rather than another urolithin, synthetic intermediate, degradation product, or undeclared blend. | Orthogonal analytical identification using HPLC or UPLC retention time, UV spectrum, and preferably LC-MS or NMR confirmation. | The identity result should match an authenticated reference standard and the approved product specification. | Full certificate of analysis, chromatograms, mass-spectrum data where applicable, reference-standard information, and batch number. |
| Assay and purity | Review the assay method, calculation basis, water correction, reference standard, and whether the result is reported on an as-is or dry basis. | Validated or verified HPLC/UPLC method; method suitability should be documented. There is no single statutory global assay limit for bulk urolithin A powder. | A buyer-defined specification such as ≥98.0% by validated HPLC may be used, but the final limit must be agreed in the purchase specification. | Method summary, validation or verification report, chromatogram, system-suitability results, and recent batch CoAs. |
| Related substances and degradation products | Check whether the method separates urolithin A from urolithin B, urolithin C, starting materials, isomers, and process-related impurities. | Stability-indicating chromatographic method with impurity reporting thresholds appropriate to the intended use. | Set individual and total impurity limits based on toxicological assessment, process capability, and destination-market requirements; do not rely on assay alone. | Impurity profile, chromatograms, forced-degradation or stress-study summary, and toxicological justification for specified impurities. |
| Residual solvents | Identify all solvents used during synthesis, purification, and crystallization, including solvents that may be introduced by reprocessing. | ICH Q3C(R8) Residual Solvents provides solvent classes and concentration limits for pharmaceutical applications. | Each detected solvent should comply with the applicable ICH Q3C limit or a stricter local/customer limit. Class 1 solvents require particularly strong controls. | GC residual-solvent report, solvent-use declaration, method details, and batch-specific results. |
| Elemental impurities and heavy metals | Assess arsenic, cadmium, lead, mercury, and other elements relevant to raw materials, catalysts, equipment, and water sources. | USP <232> and USP <233> are widely used reference approaches for elemental-impurity risk assessment and testing. | Limits depend on route of administration, daily intake, and jurisdiction. Establish limits using a documented risk assessment rather than applying one universal number. | ICP-MS or ICP-OES report, sampling plan, risk assessment, and information on catalysts and process-contact materials. |
| Microbiological quality | Check total aerobic microbial count, total yeast and mold count, and specified organisms relevant to oral products. | USP <61> and USP <62>, or equivalent Ph. Eur. microbiological methods, may be used depending on the market and product category. | Use limits appropriate to the final dosage form and local regulation; absence of specified pathogens should be demonstrated where required. | Microbiological CoA, test methods, laboratory accreditation details, and environmental-control summary. |
| Water content and physical properties | Verify moisture or loss on drying, particle size, bulk density, appearance, color, and dispersibility if the powder is used in capsules, tablets, or premixes. | Karl Fischer titration or validated loss-on-drying method; particle-size testing by laser diffraction or sieve analysis where specified. | Set limits based on stability and manufacturing performance, for example a documented moisture limit and a defined particle-size range. | Physical- and chemical-specification sheet, batch results, sampling procedure, and photos only as supplementary—not primary—evidence. |
| Pesticides and agricultural contaminants | Determine whether plant-derived starting materials or fermentation nutrients introduce pesticide residues or other agricultural contaminants. | Applicable national maximum-residue limits, Codex MRLs where relevant, and a risk-based multi-residue analytical method. | Requirements vary by destination market and product classification. Request a non-detect or legally compliant result for the relevant pesticide panel. | Multi-residue pesticide report, raw-material origin statement, agricultural-input declaration, and supply-chain traceability records. |
| Mycotoxins and other contaminants | Evaluate aflatoxins, ochratoxin A, polycyclic aromatic hydrocarbons, and other contaminants based on the starting materials and process. | Applicable food-supplement contaminant rules, Codex guidance, and validated LC-MS/MS or equivalent methods where relevant. | Testing should be justified by a documented hazard analysis; limits must follow the destination market and intended daily serving. | Contaminant risk assessment, test panel, laboratory report, and raw-material qualification records. |
| GMP and quality-system controls | Assess manufacturing controls, deviation handling, change control, CAPA, training, sanitation, computerized records, and batch-release procedures. | 21 CFR Part 111 applies to dietary supplement manufacturing in the United States; 21 CFR Parts 210/211 are pharmaceutical GMP references where applicable. EU GMP and PIC/S principles may also be relevant. | The facility should operate under a documented, audited quality system suitable for the intended product category and market. | Current GMP certificate or audit report, quality manual summary, recent inspection history, deviation/CAPA examples, and change-notification policy. |
| Laboratory competence | Confirm whether testing is performed by an appropriately qualified internal laboratory or an independent contract laboratory. | ISO/IEC 17025 covers competence, impartiality, and consistent operation of testing laboratories. | Use an ISO/IEC 17025-accredited laboratory for critical tests where feasible, with the specific test included in the accreditation scope. | Accreditation certificate, scope of accreditation, laboratory quality statement, raw data availability, and chain-of-custody records. |
| Stability and retest period | Review stability under long-term and accelerated conditions, packaging configuration, assay, impurities, moisture, and microbiological quality. | ICH Q1A(R2) is a recognized stability reference for drug substances and products; food and supplement businesses should adapt the study to their product and market. | Assign a justified retest period or shelf life based on real-time data; do not rely solely on accelerated data or an unsupported expiry date. | Stability protocol, time-point results, storage conditions, packaging description, trend analysis, and retest/expiry justification. |
| Packaging and transport | Check protection from light, oxygen, moisture, contamination, and temperature excursions during international shipment. | Packaging should be suitable for the material and compliant with applicable food-contact or product-contact requirements. | Use sealed, tamper-evident, appropriately labeled packaging with a defined transport condition and excursion-management procedure. | Packaging specification, compatibility statement, transport qualification or shipping study, tamper-evidence details, and container-closure information. |
| Traceability and batch documentation | Trace every batch from raw materials through processing, testing, release, storage, and shipment. | GMP and food-safety systems generally require documented traceability, controlled records, and recall capability. | Each lot should have a unique batch number, manufacturing date, retest or expiry date, quantity, origin, and complete release record. | Batch manufacturing record, packing record, raw-material lot list, release authorization, CoA, and recall/traceability procedure. |
| Regulatory status in the destination market | Determine whether urolithin A is treated as a food ingredient, dietary ingredient, novel food, medicinal substance, or another regulated category. | In the United States, review the FDA dietary-ingredient and new dietary ingredient framework, including FDA dietary supplement guidance. In the European Union, review the EU Novel Food framework and Union List. Other jurisdictions have separate rules. | Obtain a written market-by-market regulatory assessment before import, advertising, or sale. Regulatory acceptance in one jurisdiction does not establish acceptance globally. | Regulatory-status opinion, ingredient dossier, manufacturing description, safety data, proposed use level, labeling review, and any required notification or authorization evidence. |
| Claims and labeling support | Ensure that dosage, structure/function claims, health claims, warnings, allergen statements, and use instructions are lawful in the target market. | Claims rules differ substantially between jurisdictions and may depend on whether the product is a food, supplement, or medicine. | Use only claims supported by permitted regulatory pathways and appropriate human or technical evidence; avoid implying disease treatment without authorization. | Label artwork, claims substantiation file, serving-size rationale, allergen/GMO statements, and local regulatory review. |
| Commercial and supply continuity risk | Evaluate minimum order quantity, lead time, production capacity, dual sourcing, change notification, and continuity of analytical quality. | Quality agreements and supplier-qualification programs should address changes to process, site, raw materials, specifications, and analytical methods. | Approve suppliers only after technical qualification, sample testing, pilot-scale evaluation, and agreement on written change-control requirements. | Quality agreement, supplier questionnaire, audit report, capacity statement, change-control clause, and three or more representative batch CoAs where available. |
