AX-2026-041830
Thymosin α1 · 5 mg declared · Flourishglobal Peptide Biotech (Chengdu) Co., Ltd. · lot FGP-2511-H2692
- Report ID
- AX-2026-041830
- Compound
- Thymosin α1
- Compound class
- Tissue-repair and immunomodulatory peptides
- Supplier
- FGP — Flourishglobal Peptide Biotech (Chengdu) Co., Ltd.
- Batch / lot
- FGP-2511-H2692
- Declared label claim
- 5mg
- Laboratory
- PeptideMeter
- Assay date
- 09 Feb 2026
- Submitted
- 10 Feb 2026
- Quarter
- 2026-Q1
- Submitter
- h.dumitru
- Sample provenance
- Supplier-supplied
Results
Measured against the index acceptance specification for the tissue-repair and immunomodulatory 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 | RP-HPLC, 28 min gradient, 214 nm | 98.89 | % area | ≥ 97.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.11 | % area | ≤ 2.5 | PASS |
| Largest single impurity | RP-HPLC — aspartimide (−18 Da) | 0.72 | % area | ≤ 1.00 | PASS |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 89.45 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 88.46 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 5.60 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 4.954 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 99.1 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.04 | % | ≤ 10.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 4.52 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.99 | % | — | NOT TESTED |
| Endotoxin | not ordered on this submission | not determined | — | ≤ 5.0 | NOT TESTED |
| Sterility | not ordered on this submission | not determined | — | no growth | NOT TESTED |
| 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 | 4.60 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 11.95 | min | 11.94 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.88 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 77,708 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs deamidated Asn (+1 Da) | 1.81 | — | no index criterion | REPORTED |
Chromatogram and peak integration
The figure is drawn from the table. It is not an independent illustration — if a number in the table changed, the trace would change with it.
| # | Peak | RT | Area (µV·s) | % area | Δ mass (Da) |
|---|---|---|---|---|---|
| 1 | Thymosin α1 — main peak | 11.95 | 4,806,361 | 98.89 | — |
| 2 | aspartimide (−18 Da) | 12.34 | 34,994 | 0.72 | -18.011 |
| 3 | des-acetyl Tα1 (−42 Da) | 11.32 | 9,721 | 0.20 | -42.011 |
| 4 | truncated (1-24) | 10.79 | 6,318 | 0.13 | -487.229 |
| 5 | deamidated Asn (+1 Da) | 11.63 | 2,916 | 0.06 | +0.984 |
| Closure check — purity + Σ impurities | 100.00 | CLOSES | |||
Reporting threshold 0.05 % area. Peaks below it are not reported and are therefore excluded from the total, which overstates purity by their sum — see peak integration.
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.
| Component | Determination | %w/w of cake |
|---|---|---|
| Water | Karl Fischer | 5.04 |
| Counter-ion (acetate) | ion chromatography | 4.52 |
| Residual solvent + inorganic residue | estimated | 0.99 |
| Total peptide content | by difference | 89.45 |
| Total | 100.00 CLOSES | |
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) | 99.72 | 98.89 | divergence +0.83 pp vs batch median |
| Total impurities (% area) | 0.28 | 1.11 | |
| Largest single impurity (% area) | not stated | 0.72 | |
| Water (%) | 4.7 | 5.04 | |
| Counter-ion (%) | 7.8 | 4.52 | |
| Peptide content (%w/w) | 86.9 | 89.45 | |
| Endotoxin (EU/mg) | not stated | not determined | |
| Method stated on certificate | YES | — | column, gradient and wavelength given |
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, 8 d) → assay. Submitter did not handle the vial.
- Assay date
- 09 Feb 2026
- Submitted to the index
- 10 Feb 2026
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot FGP-2511-H2692 n=3
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041831 | FGP-2511-H2692 | PeptideMeter | 2026-Q1 | 99.55 | 5.09 | 95.2 | Supplier-supplied | 0 | PASS |
| AX-2026-041832 | FGP-2511-H2692 | Medutest | 2026-Q1 | 98.41 | 4.46 | — | Supplier-supplied | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043213 | SGN | SGN-2512-Y1213 | Janoshik | 2026-Q2 | 99.13 | 7.01 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041468 | QYB | QYB-2511-V6148 | Kestrel | 2026-Q1 | 99.44 | 2.86 | 101.7 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041831 | FGP | FGP-2511-H2692 | PeptideMeter | 2026-Q1 | 99.55 | 5.09 | 95.2 | Supplier-supplied | 0 | PASS |
| AX-2026-041832 | FGP | FGP-2511-H2692 | Medutest | 2026-Q1 | 98.41 | 4.46 | — | Supplier-supplied | 0 | PASS |
| AX-2025-019905 | SWB | SWB-2503-S5672 | Janoshik | 2025-Q3 | 98.96 | 3.36 | — | Supplier-supplied | 0 | PASS |
| AX-2025-020891 | CPC | CPC-2504-M1855 | Janoshik | 2025-Q3 | 98.14 | 5.19 | 104.6 | Supplier-supplied | 0 | PASS |
| AX-2025-019906 | SWB | SWB-2503-S5672 | Janoshik | 2025-Q3 | 99.71 | 3.18 | — | Supplier-supplied | 0 | PASS |
| AX-2025-019909 | SWB | SWB-2503-S5672 | Janoshik | 2025-Q3 | 99.24 | 3.04 | 102.0 | Supplier-supplied | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041742 | Tirzepatide | FGP-2603-L9714 | Janoshik | 2026-Q3 | 99.37 | 2.43 | 105.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041767 | Semaglutide | FGP-2602-M1508 | PeptideMeter | 2026-Q3 | 98.65 | 2.54 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-041741 | Tirzepatide | FGP-2603-L9714 | PeptideMeter | 2026-Q3 | 98.62 | 2.57 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041772 | Semaglutide | FGP-2602-M1508 | Janoshik | 2026-Q3 | 99.79 | 3.03 | 107.5 | Supplier-supplied | 0 | PASS |
| AX-2026-041770 | Semaglutide | FGP-2602-M1508 | VendorInvestigate | 2026-Q3 | 99.33 | 1.48 | 90.3 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041769 | Semaglutide | FGP-2602-M1508 | Janoshik | 2026-Q3 | 99.13 | 2.55 | 92.9 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041768 | Semaglutide | FGP-2602-M1508 | Janoshik | 2026-Q3 | 98.85 | 2.20 | 90.3 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041771 | Semaglutide | FGP-2602-M1508 | Janoshik | 2026-Q3 | 99.41 | 2.31 | — | Supplier-supplied | 0 | PASS |