AX-2025-019996
Follistatin-344 · 0.1 mg declared · Shanghai ERP Biotechnology Co., Ltd. · lot ERP-2411-Y6431
N/AN/A
- Report ID
- AX-2025-019996
- Compound
- Follistatin-344
- Compound class
- Growth-hormone axis peptides
- Supplier
- ERP — Shanghai ERP Biotechnology Co., Ltd.
- Batch / lot
- ERP-2411-Y6431
- Declared label claim
- 0.10mg
- Laboratory
- Medutest
- Assay date
- 03 Feb 2025
- Submitted
- 04 Feb 2025
- Quarter
- 2025-Q1
- Submitter
- so.broberg
- Sample provenance
- Supplier-supplied
Section 1
Results
Measured against the index acceptance specification for the growth-hormone axis peptides class. A specification is a decision the index made; a result is a measurement. See where each threshold came from.
| Parameter | Method | Result | Unit | Index spec | |
|---|---|---|---|---|---|
| Purity | not a defined quantity for this substance | N/A | — | not applicable | NOT TESTED |
| Peptide content | not ordered on this submission | not determined | — | required to check label claim | NOT TESTED |
| Water content | Karl Fischer, coulometric, duplicate | 2.97 | % | ≤ 9.0 | PASS |
| Counter-ion | no ionisable counter-ion expected | N/A | — | not applicable | NOT TESTED |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.29 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.39 | EU/mg | ≤ 5.0 | PASS |
| Sterility | membrane filtration, USP <71>, 14 d | No growth at 14 d | — | no growth | PASS |
| Appearance | visual, diffuse light, black and white background | White lyophilised cake, intact | — | white to off-white intact cake | PASS |
| Reconstitution clarity | reconstituted per submitter procedure | Clear, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 8.18 | — | 2.5 – 8.0 | FAIL |
Section 4
Gravimetric mass balance
Water, counter-ion, residual and total peptide content are exhaustive and mutually exclusive categories. They must account for 100 % of the cake mass. The index closes this to within 0.02 pp and the build asserts it.
Supplier certificate, as declared
The supplier's own figures for this lot, beside the independent measurement. Divergence is assessed against the batch median, not against this single report — see rule AX-R05.
| Figure | Supplier COA | This report | Index note |
|---|---|---|---|
| Purity (% area) | 99.0 | N/A | |
| Total impurities (% area) | not stated | N/A | |
| Largest single impurity (% area) | not stated | N/A | |
| Water (%) | 6.3 | 2.97 | |
| Counter-ion (%) | not stated | N/A | |
| Peptide content (%w/w) | not stated | not determined | |
| Endotoxin (EU/mg) | not stated | 0.39 | |
| Method stated on certificate | NO | — | no method section — the result cannot be reconciled against any other |
Section 5
Provenance and caveats
Where a sample came from changes the weight of the evidence. The index treats it as a first-class field.
- Sample provenance
- Supplier-supplied
- Evidentiary weight
- Weaker evidence. Read with the caveat below.
- Chain of custody
- Supplier despatch → laboratory direct (courier, cold pack, 12 d) → assay. Submitter did not handle the vial.
- Assay date
- 03 Feb 2025
- Submitted to the index
- 04 Feb 2025
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- N/A
Section 6
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Section 7
Related records
Same batch — lot ERP-2411-Y6431 n=0
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-019993 | ERP-2411-Y6431 | Nordanalyt | 2025-Q1 | N/A | 3.72 | — | Supplier-supplied | 1 | N/A |
| AX-2025-019994 | ERP-2411-Y6431 | Medutest | 2025-Q1 | N/A | 2.74 | — | Buyer-sourced | 1 | N/A |
| AX-2025-019995 | ERP-2411-Y6431 | Medutest | 2025-Q1 | N/A | 2.81 | — | Supplier-supplied | 1 | N/A |
| AX-2025-019997 | ERP-2411-Y6431 | VendorInvestigate | 2025-Q1 | N/A | 2.68 | — | Buyer-sourced | 1 | N/A |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2025-019993 | ERP | ERP-2411-Y6431 | Nordanalyt | 2025-Q1 | N/A | 3.72 | — | Supplier-supplied | 1 | N/A |
| AX-2025-019995 | ERP | ERP-2411-Y6431 | Medutest | 2025-Q1 | N/A | 2.81 | — | Supplier-supplied | 1 | N/A |
| AX-2025-019997 | ERP | ERP-2411-Y6431 | VendorInvestigate | 2025-Q1 | N/A | 2.68 | — | Buyer-sourced | 1 | N/A |
| AX-2025-019994 | ERP | ERP-2411-Y6431 | Medutest | 2025-Q1 | N/A | 2.74 | — | Buyer-sourced | 1 | N/A |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042574 | TB-500 | ERP-2605-S8022 | VendorInvestigate | 2026-Q3 | 99.54 | 2.91 | 96.4 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042535 | Tesamorelin | ERP-2604-W7280 | Janoshik | 2026-Q3 | 99.19 | 3.89 | 92.7 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042577 | TB-500 | ERP-2605-S8022 | Janoshik | 2026-Q3 | 99.51 | 3.45 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042542 | Tesamorelin | ERP-2604-W7280 | Janoshik | 2026-Q3 | 98.54 | 4.58 | 103.1 | Supplier-supplied | 2 | FAIL |
| AX-2026-042547 | Survodutide | ERP-2605-E7682 | PeptideMeter | 2026-Q3 | 98.25 | 5.44 | 93.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042540 | Tesamorelin | ERP-2604-W7280 | Kestrel | 2026-Q3 | 99.72 | 3.47 | 103.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042575 | TB-500 | ERP-2605-S8022 | Janoshik | 2026-Q3 | 99.93 | 3.36 | 95.5 | Supplier-supplied | 0 | PASS |
| AX-2026-042539 | Tesamorelin | ERP-2604-W7280 | Janoshik | 2026-Q3 | 98.77 | 4.30 | 89.9 | Buyer-sourced | 2 | MARGINAL |