AX-2026-041550
TB-500 · 2 mg declared · ChinaPeptides Co., Ltd. (QYAOBIO) · lot QYB-2511-H6699
- Report ID
- AX-2026-041550
- Compound
- TB-500
- Compound class
- Tissue-repair and immunomodulatory peptides
- Supplier
- QYB — ChinaPeptides Co., Ltd. (QYAOBIO)
- Batch / lot
- QYB-2511-H6699
- Declared label claim
- 2mg
- Laboratory
- Nordanalyt Laboratories
- Assay date
- 18 Feb 2026
- Submitted
- 08 Mar 2026
- Quarter
- 2026-Q1
- Submitter
- v.balogun
- 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, 35 min gradient, 214 nm | 99.67 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.33 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — C-terminal amide (−1 Da) | 0.21 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 887.4964 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 887.5003 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +4.4 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 86.51 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 86.22 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.43 | mg | 2 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 2.095 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 104.8 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.16 | % | ≤ 10.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 7.04 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.29 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 1.41 | EU/mg | ≤ 5.0 | PASS |
| 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 | 5.25 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 35 min gradient | 9.05 | min | 9.07 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.11 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 65,431 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Thr]-diastereomer | 0.88 | — | 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 | TB-500 — main peak | 9.05 | 4,844,271 | 99.67 | — |
| 2 | C-terminal amide (−1 Da) | 9.26 | 10,207 | 0.21 | -0.984 |
| 3 | [D-Thr]-diastereomer | 8.92 | 2,916 | 0.06 | 0.000 |
| 4 | des-Gln truncate (−128 Da) | 8.77 | 1,458 | 0.03 | -128.059 |
| 5 | des-acetyl TB-500 (−42 Da) | 8.44 | 1,458 | 0.03 | -42.011 |
| 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.
Mass spectrum and identity
Theoretical monoisotopic mass 887.4964 Da, computed from C39H69N9O14. 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 (%) |
|---|---|---|---|---|
| 2+ | 444.7555 | 444.7574 | 0.0019 | 59.0 |
| 1+ | 888.5037 | 888.5076 | 0.0039 | 100.0 |
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 | 6.16 |
| Counter-ion (acetate) | ion chromatography | 7.04 |
| Residual solvent + inorganic residue | estimated | 0.29 |
| Total peptide content | by difference | 86.51 |
| 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) | 99.52 | 99.67 | divergence +0.13 pp vs batch median |
| Total impurities (% area) | 0.48 | 0.33 | |
| Largest single impurity (% area) | 0.19 | 0.21 | |
| Water (%) | 5.2 | 6.16 | |
| Counter-ion (%) | not stated | 7.04 | |
| Peptide content (%w/w) | 90.0 | 86.51 | |
| Endotoxin (EU/mg) | not stated | 1.41 | |
| 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, 11 d) → assay. Submitter did not handle the vial.
- Assay date
- 18 Feb 2026
- Submitted to the index
- 08 Mar 2026
- Laboratory
- Nordanalyt Laboratories, Uppsala, Sweden
- Method basis
- 35 min gradient · high-resolution MS
- Verification status
- VERIFIED
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot QYB-2511-H6699 n=14
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041548 | QYB-2511-H6699 | PeptideMeter | 2026-Q1 | 99.44 | 5.76 | 96.7 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041549 | QYB-2511-H6699 | Medutest | 2026-Q1 | 99.38 | 5.63 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041551 | QYB-2511-H6699 | Janoshik | 2026-Q1 | 99.48 | 6.14 | 98.1 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041552 | QYB-2511-H6699 | Nordanalyt | 2026-Q1 | 99.14 | 6.71 | 105.8 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041553 | QYB-2511-H6699 | VendorInvestigate | 2026-Q1 | 99.32 | 6.10 | 102.2 | Buyer-sourced | 2 | MARGINAL |
| AX-2026-041554 | QYB-2511-H6699 | Janoshik | 2026-Q1 | 99.54 | 5.50 | 101.0 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041555 | QYB-2511-H6699 | Janoshik | 2026-Q1 | 98.92 | 7.07 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041556 | QYB-2511-H6699 | Nordanalyt | 2026-Q1 | 99.70 | 6.58 | 94.0 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041557 | QYB-2511-H6699 | Janoshik | 2026-Q1 | 99.12 | 6.98 | 98.7 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041558 | QYB-2511-H6699 | Janoshik | 2026-Q1 | 99.47 | 6.25 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041559 | QYB-2511-H6699 | PeptideMeter | 2026-Q1 | 99.40 | 6.10 | 90.6 | Supplier-supplied | 3 | FAIL |
| AX-2026-041560 | QYB-2511-H6699 | Kestrel | 2026-Q1 | 99.38 | 5.92 | 106.5 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041561 | QYB-2511-H6699 | Janoshik | 2026-Q1 | 98.95 | 5.87 | — | Supplier-supplied | 2 | MARGINAL |
Cross-sections
- All TB-500 records n=356
- All QYB records n=325
- All Nordanalyt records n=511
- All 2026-Q1 records n=832
- TB-500 by supplier
- TB-500 impurity profile
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041847 | JEEP | JEEP-2602-V3434 | Nordanalyt | 2026-Q3 | 99.72 | 3.85 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042574 | ERP | ERP-2605-S8022 | VendorInvestigate | 2026-Q3 | 99.54 | 2.91 | 96.4 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-042577 | ERP | ERP-2605-S8022 | Janoshik | 2026-Q3 | 99.51 | 3.45 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041845 | JEEP | JEEP-2602-V3434 | Janoshik | 2026-Q3 | 99.72 | 4.04 | 102.2 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041921 | JEEP | JEEP-2605-M4874 | Janoshik | 2026-Q3 | 99.90 | 1.76 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041922 | JEEP | JEEP-2605-M4874 | Janoshik | 2026-Q3 | 99.41 | 2.60 | 95.7 | Laboratory-retained | 2 | MARGINAL |
| AX-2026-041928 | JEEP | JEEP-2605-M4874 | Janoshik | 2026-Q3 | 99.88 | 1.84 | 92.8 | Laboratory-retained | 2 | MARGINAL |
| AX-2026-041849 | JEEP | JEEP-2602-V3434 | VendorInvestigate | 2026-Q3 | 99.73 | 3.60 | 88.6 | Buyer-sourced | 2 | MARGINAL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041453 | Retatrutide | QYB-2604-B5660 | VendorInvestigate | 2026-Q3 | 98.02 | 2.55 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041454 | Retatrutide | QYB-2604-B5660 | Janoshik | 2026-Q3 | 98.84 | 2.77 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041538 | Retatrutide | QYB-2602-G6308 | Medutest | 2026-Q3 | 98.50 | 2.85 | — | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041456 | Retatrutide | QYB-2604-B5660 | Janoshik | 2026-Q3 | 98.23 | 3.24 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041452 | Retatrutide | QYB-2604-B5660 | Nordanalyt | 2026-Q3 | 98.50 | 3.36 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041427 | Ipamorelin | QYB-2605-H4298 | Janoshik | 2026-Q3 | 99.93 | 4.12 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041488 | PT-141 (Bremelanotide) | QYB-2607-L5615 | Janoshik | 2026-Q3 | 99.93 | 3.79 | — | Supplier-supplied | 0 | PASS |
| AX-2026-041459 | Retatrutide | QYB-2604-B5660 | VendorInvestigate | 2026-Q3 | 97.91 | 2.84 | 92.2 | Buyer-sourced | 1 | MARGINAL |