AX-2025-019052
Thymosin α1 · 1.6 mg declared · Asymchem Laboratories (Tianjin) Co., Ltd. · lot ASY-{CAT}-2031
PASSVERIFIED
- Report ID
- AX-2025-019052
- Compound
- Thymosin α1
- Compound class
- Tissue-repair and immunomodulatory peptides
- Supplier
- ASY — Asymchem Laboratories (Tianjin) Co., Ltd.
- Batch / lot
- ASY-{CAT}-2031
- Declared label claim
- 2mg
- Laboratory
- Janoshik Analytical
- Assay date
- 18 Apr 2025
- Submitted
- 21 Apr 2025
- Quarter
- 2025-Q2
- Submitter
- ro.kjaer
- Sample provenance
- Buyer-sourced
Section 1
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, 30 min gradient, 214 nm | 99.21 | % area | ≥ 97.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.79 | % area | ≤ 2.5 | PASS |
| Largest single impurity | RP-HPLC — des-acetyl Tα1 (−42 Da) | 0.54 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 3106.5493 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 3106.5422 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -2.3 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 91.30 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 90.58 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 1.73 | mg | 1.6 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 1.567 | mg | 1.6 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 97.9 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 3.54 | % | ≤ 10.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 4.23 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.93 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.19 | 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 cake, partial shrinkage from vial wall | — | white to off-white intact cake | FAIL |
| 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 | 5.43 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 12.68 | min | 12.72 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.10 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 29,195 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs deamidated Asn (+1 Da) | 1.12 | — | no index criterion | REPORTED |
Section 2
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 | 12.68 | 4,821,914 | 99.21 | — |
| 2 | des-acetyl Tα1 (−42 Da) | 12.00 | 26,246 | 0.54 | -42.011 |
| 3 | truncated (1-24) | 11.44 | 7,290 | 0.15 | -487.229 |
| 4 | aspartimide (−18 Da) | 13.10 | 2,430 | 0.05 | -18.011 |
| 5 | deamidated Asn (+1 Da) | 12.34 | 2,430 | 0.05 | +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.
Section 3
Mass spectrum and identity
Theoretical monoisotopic mass 3106.5493 Da, computed from C129H215N33O55. All ppm figures on this site are against monoisotopic values — see why that matters.
| Charge | Theoretical m/z | Observed m/z | Δ m/z | Rel. abundance (%) |
|---|---|---|---|---|
| 5+ | 622.3171 | 622.3157 | -0.0014 | 9.5 |
| 4+ | 777.6446 | 777.6428 | -0.0018 | 58.0 |
| 3+ | 1036.5237 | 1036.5213 | -0.0024 | 100.0 |
| 2+ | 1554.2819 | 1554.2784 | -0.0035 | 53.9 |
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.
| Component | Determination | %w/w of cake |
|---|---|---|
| Water | Karl Fischer | 3.54 |
| Counter-ion (acetate) | ion chromatography | 4.23 |
| Residual solvent + inorganic residue | estimated | 0.93 |
| Total peptide content | by difference | 91.30 |
| 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) | 99.90 | 99.21 | divergence +0.53 pp vs batch median |
| Total impurities (% area) | 0.10 | 0.79 | |
| Largest single impurity (% area) | 0.04 | 0.54 | |
| Water (%) | not stated | 3.54 | |
| Counter-ion (%) | not stated | 4.23 | |
| Peptide content (%w/w) | not stated | 91.30 | |
| Endotoxin (EU/mg) | not stated | 0.19 | |
| Method stated on certificate | YES | — | column, gradient and wavelength given |
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
- Buyer-sourced
- Evidentiary weight
- Strongest available evidence in this index.
- Chain of custody
- Retail purchase → submitter (2–8 °C, 23 d) → laboratory (courier, ambient, 6 d) → assay.
- Assay date
- 18 Apr 2025
- Submitted to the index
- 21 Apr 2025
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- VERIFIED
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 ASY-{CAT}-2031 n=7
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-019049 | ASY-{CAT}-2031 | Janoshik | 2025-Q2 | 99.39 | 4.05 | 98.5 | Buyer-sourced | 0 | PASS |
| AX-2025-019050 | ASY-{CAT}-2031 | Janoshik | 2025-Q2 | 98.93 | 4.36 | — | Buyer-sourced | 0 | PASS |
| AX-2025-019051 | ASY-{CAT}-2031 | PeptideMeter | 2025-Q2 | 99.37 | 4.20 | — | Buyer-sourced | 0 | PASS |
| AX-2025-019053 | ASY-{CAT}-2031 | PeptideMeter | 2025-Q2 | 99.27 | 3.69 | 91.1 | Buyer-sourced | 0 | PASS |
| AX-2025-019054 | ASY-{CAT}-2031 | Janoshik | 2025-Q2 | 99.42 | 4.28 | — | Buyer-sourced | 0 | PASS |
| AX-2025-019055 | ASY-{CAT}-2031 | Medutest | 2025-Q2 | 99.54 | 3.99 | 100.8 | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041996 | AMB | AMB-2511-B5683 | VendorInvestigate | 2026-Q2 | 99.31 | 4.20 | 91.2 | Buyer-sourced | 0 | PASS |
| AX-2026-041995 | AMB | AMB-2511-B5683 | PeptideMeter | 2026-Q2 | 98.86 | 4.00 | 104.5 | Buyer-sourced | 0 | PASS |
| AX-2026-041998 | AMB | AMB-2511-B5683 | Nordanalyt | 2026-Q2 | 99.08 | 3.83 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043232 | SGN | SGN-2512-Y9621 | Janoshik | 2026-Q2 | 99.42 | 6.88 | 89.1 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041999 | AMB | AMB-2511-B5683 | Medutest | 2026-Q2 | 99.93 | 3.95 | 102.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041997 | AMB | AMB-2511-B5683 | PeptideMeter | 2026-Q2 | 99.11 | 4.26 | 104.3 | Buyer-sourced | 0 | PASS |
| AX-2026-041442 | QYB | QYB-2511-V5408 | Kestrel | 2026-Q1 | 99.82 | 2.35 | 96.1 | Buyer-sourced | 0 | PASS |
| AX-2026-041438 | QYB | QYB-2511-V5408 | Janoshik | 2026-Q1 | 99.80 | 2.70 | 105.2 | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041776 | TB-500 | ASY-{CAT}-2167 | Janoshik | 2026-Q3 | 99.92 | 4.61 | 98.2 | Buyer-sourced | 0 | PASS |
| AX-2026-041777 | TB-500 | ASY-{CAT}-2167 | PeptideMeter | 2026-Q3 | 99.78 | 4.09 | 92.8 | Buyer-sourced | 0 | PASS |
| AX-2026-041786 | Retatrutide | ASY-{CAT}-2288 | VendorInvestigate | 2026-Q3 | 98.78 | 6.59 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041782 | TB-500 | ASY-{CAT}-2167 | Nordanalyt | 2026-Q3 | 99.93 | 3.94 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041793 | Retatrutide | ASY-{CAT}-2288 | Nordanalyt | 2026-Q3 | 98.34 | 6.16 | 104.8 | Buyer-sourced | 0 | PASS |
| AX-2026-041784 | Retatrutide | ASY-{CAT}-2288 | PeptideMeter | 2026-Q3 | 98.15 | 6.26 | 91.9 | Buyer-sourced | 0 | PASS |
| AX-2026-041774 | TB-500 | ASY-{CAT}-2167 | PeptideMeter | 2026-Q3 | 99.93 | 4.41 | 96.2 | Buyer-sourced | 0 | PASS |
| AX-2026-041780 | TB-500 | ASY-{CAT}-2167 | Janoshik | 2026-Q3 | 99.93 | 3.48 | 102.5 | Buyer-sourced | 1 | FAIL |