AX-2026-042502
Humanin (HNG) · 5 mg declared · Shanghai ERP Biotechnology Co., Ltd. · lot ERP-2601-P6603
- Report ID
- AX-2026-042502
- Compound
- Humanin (HNG)
- Compound class
- Metabolic and mitochondrial peptides
- Supplier
- ERP — Shanghai ERP Biotechnology Co., Ltd.
- Batch / lot
- ERP-2601-P6603
- Declared label claim
- 5mg
- Laboratory
- Medutest
- Assay date
- 04 Mar 2026
- Submitted
- 11 Mar 2026
- Quarter
- 2026-Q1
- Submitter
- b.baptista
- Sample provenance
- Supplier-supplied
Results
Measured against the index acceptance specification for the metabolic and mitochondrial 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, 25 min gradient, 214 nm | 98.97 | % area | ≥ 97.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.03 | % area | ≤ 2.5 | PASS |
| Largest single impurity | RP-HPLC — deamidated (+1 Da) | 0.74 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 2685.3153 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 2685.3392 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +8.9 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 90.64 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 89.71 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 5.10 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 4.575 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 91.5 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.19 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 4.16 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 1.01 | % | — | 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 | Off-white lyophilised cake, intact | — | white to off-white intact cake | PASS |
| Reconstitution clarity | reconstituted per submitter procedure | Clear after 90 s gentle swirling, no particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 4.38 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 10.16 | min | 10.28 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.86 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 54,750 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs wild-type humanin (Ser14, −42 Da) | 0.70 | — | 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 | Humanin (HNG) — main peak | 10.16 | 4,810,249 | 98.97 | — |
| 2 | deamidated (+1 Da) | 9.93 | 35,966 | 0.74 | +0.984 |
| 3 | Met sulfoxide (+16 Da) | 9.81 | 5,832 | 0.12 | +15.995 |
| 4 | wild-type humanin (Ser14, −42 Da) | 10.04 | 4,374 | 0.09 | -42.011 |
| 5 | truncated (1-20) | 9.04 | 3,888 | 0.08 | -472.245 |
| 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 2685.3153 Da, computed from C119H182N30O32S. 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+ | 538.0703 | 538.0751 | 0.0048 | 8.6 |
| 4+ | 672.3361 | 672.3421 | 0.0060 | 51.4 |
| 3+ | 896.1124 | 896.1203 | 0.0079 | 100.0 |
| 2+ | 1343.6649 | 1343.6769 | 0.0120 | 53.7 |
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 | 4.19 |
| Counter-ion (acetate) | ion chromatography | 4.16 |
| Residual solvent + inorganic residue | estimated | 1.01 |
| Total peptide content | by difference | 90.64 |
| 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) | 99.37 | 98.97 | divergence +0.49 pp vs batch median |
| Total impurities (% area) | 0.63 | 1.03 | |
| Largest single impurity (% area) | 0.44 | 0.74 | |
| Water (%) | 1.7 | 4.19 | |
| Counter-ion (%) | not stated | 4.16 | |
| Peptide content (%w/w) | not stated | 90.64 | |
| 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, 9 d) → assay. Submitter did not handle the vial.
- Assay date
- 04 Mar 2026
- Submitted to the index
- 11 Mar 2026
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- IDENTITY CONSISTENT
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot ERP-2601-P6603 n=6
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042503 | ERP-2601-P6603 | Medutest | 2026-Q1 | 98.77 | 3.55 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042504 | ERP-2601-P6603 | Janoshik | 2026-Q1 | 99.45 | 4.32 | 100.7 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042505 | ERP-2601-P6603 | Janoshik | 2026-Q1 | 99.35 | 3.74 | 101.7 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042506 | ERP-2601-P6603 | Janoshik | 2026-Q1 | 98.37 | 3.83 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-042507 | ERP-2601-P6603 | Janoshik | 2026-Q1 | 98.79 | 3.07 | 107.3 | Supplier-supplied | 1 | MARGINAL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041973 | TFC | TFC-2605-U5564 | Janoshik | 2026-Q3 | 99.62 | 7.03 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-041980 | TFC | TFC-2605-U5564 | Janoshik | 2026-Q3 | 99.90 | 7.01 | 88.6 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041979 | TFC | TFC-2605-U5564 | Nordanalyt | 2026-Q3 | 99.73 | 6.64 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041981 | TFC | TFC-2605-U5564 | Medutest | 2026-Q3 | 99.87 | 6.84 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041975 | TFC | TFC-2605-U5564 | Nordanalyt | 2026-Q3 | 99.93 | 6.86 | 91.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041977 | TFC | TFC-2605-U5564 | Medutest | 2026-Q3 | 99.19 | 6.76 | 103.8 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041972 | TFC | TFC-2605-U5564 | Janoshik | 2026-Q3 | 99.48 | 6.11 | 92.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-041974 | TFC | TFC-2605-U5564 | Janoshik | 2026-Q3 | 99.93 | 6.31 | 96.6 | Supplier-supplied | 1 | MARGINAL |
| 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 |