| Identity and chemical form | 20% | Current specification, certificate of analysis, CAS or substance identification, declared salt form, and representative chromatogram | The specification clearly identifies the 5-MTHF form, such as calcium or glucosamine salt, and matches the finished-product label claim | Unclear salt form, inconsistent naming, missing identity test, or a certificate that does not match the lot |
| Potency and analytical control | 25% | Validated or qualified HPLC/UPLC method, assay result, impurity profile, moisture result, and laboratory accreditation details where applicable | Lot-specific assay meets the agreed product specification; the analytical method distinguishes 5-MTHF from related folate compounds and degradation products | Only a generic “purity” number, no test method, no chromatogram, or results supplied only from an unverifiable laboratory |
| Stability and packaging | 20% | Real-time or accelerated stability data, retest or expiry policy, packaging specification, storage conditions, and light/oxygen protection information | A documented shelf-life rationale supports the proposed expiry period, with sealed moisture- and light-protective packaging and defined storage conditions | No stability data, open-ended expiry claims, transparent packaging without justification, or storage instructions that are absent or contradictory |
| Quality system and regulatory documentation | 20% | Current GMP or food-safety certification, audit report or questionnaire, allergen statement, non-GMO statement where relevant, and change-control procedure | The manufacturing site and certificate scope cover the supplied material; traceability and deviation/CAPA procedures are documented | Certificate belongs to another site, expired certification, unsupported “GMP” wording, or inability to provide traceability records |
| Supply continuity and commercial reliability | 15% | Documented manufacturing location, batch-size information, lead-time commitment, minimum order quantity, forecast process, and business-continuity plan | The supplier provides a written lead-time range, lot availability, backup arrangements, and advance notice of material or process changes | Unstable lead times, unexplained specification changes, no contingency plan, or dependence on an undisclosed third party |