Match each specification or statement to its evidence
| Evaluation question | Reference | Scope |
|---|---|---|
| Identity, purity and assay | TDS · 22 July 2026 | Specification limits; obtain a batch COA for actual results. |
| Shelf life and storage | 2026 TDS and three-batch stability summary | 36-month stated shelf life; available observations cover 24 months. |
| Human research | 2026 publication · DOI 10.34297/AJBSR.2026.32.004130 | Exploratory eight-week trial, 27 completers; design, results and limitations. |
| Manufacturing facility | NSF GMP facility directory | Verify the facility and current registration scope. |
| Self-affirmed GRAS | Summary statement · 4 December 2025 | Review the stated use and request the supporting dossier; not FDA approval. |
Which documents should your team review?
Technical data sheet (TDS)
Ingredient identity, specification limits, handling and storage requirements.
Review point: Confirm the revision and applicable grade.
Certificate of analysis (COA)
Analytical results for a specific manufactured batch.
Review point: Check the lot number, dates, methods and acceptance criteria.
Laboratory test reports
Results for the submitted sample and stated testing panel.
Review point: Review laboratory identity, sample ID, methods and detection limits.
Safety data sheet (SDS)
Hazard communication and ingredient handling information.
Review point: Use the current version applicable to the material.
Stability information
Observations under defined storage and packaging conditions.
Review point: Review time points, batches and the basis of any shelf-life claim.
Read laboratory results in their tested scope
The EquoPro quality dossier covers assay and optical rotation, microbiology, heavy metals, selected allergen markers and a specified hormone panel. Results apply to the tested samples, methods and limits in each report.
- Compare a batch COA with the current specification before using it for release decisions.
- “Not detected” means not detected at the stated method limit; it does not establish absence under every method or in every batch.
- A negative result for selected hormone markers does not mean S-equol has no biological activity.
Testing and safety documentation register
The report references below support initial supplier qualification. Request the full report for its methods, acceptance criteria and detection limits before making a release or formulation decision.
Assay & optical rotation
SGS / single submitted sampleAnalytical assay and optical rotation assessment. Read alongside the TDS identity and purity specifications.
Microbiology & heavy metals
SGS / 2025 batch YGIF25062301Batch-specific test results covering microbiological and heavy-metal parameters. Request the report for measured values and methods.
Selected allergen markers
SGS / 2025 lot YGIF25121501The summary reports no detectable soy-allergen marker under the stated method and quantification limit. The result applies to the tested sample.
Hormone screening
SGS / 2025 lot YGIF25070201The supplier overview describes a 53-marker screening panel, with the reported markers not detected at the stated limits. Confirm the analyte list in the full report.
Acute oral toxicity study
Mouse study / supplier summaryThe summary reports an acute oral LD50 above 5,000 mg/kg under the study conditions. This animal endpoint does not establish a human recommended intake or long-term safety.
Safety data sheet
2026 MSDSHandling and hazard-communication information for the ingredient. Request the applicable controlled version.
Separate ingredient stability from product stability
The available ingredient stability summary covers three batches assessed to 24 months at room temperature. The 2026 TDS states a 36-month shelf life. Review the full data package and current controlled specification to understand the basis and conditions for that claim.
A finished capsule, tablet or blend still needs its own compatibility, packaging and stability assessment.
NSF GMP facility registration
Shanghai EGT Synbio Group Co., Ltd. appears in the NSF GMP directory as a manufacturing facility at Building 7, No. 1299 Ziyue Road, Minhang District, Shanghai.
The supplied 2026 registration summary lists reference C0783444-DS-5 and an expiry date of 26 February 2027. Check the current certificate and directory for the applicable facility and scope.
Check the NSF official listing ↗Official directory reviewed 10 October 2026; the retrieved listing was dated 29 September 2026. Facility registration does not certify every finished product or establish a product’s efficacy.
Self-affirmed GRAS summary statement
The dossier includes an EquoPro self-affirmed GRAS summary statement dated 4 December 2025. It describes an independent expert-panel safety conclusion for the adult use specified in that document.
Request the underlying dossier, panel assessment and precise intended-use conditions for your technical review. The supplied image is a summary statement; it is not an FDA approval letter or an FDA “no questions” response.
View the dated summary statement
