AX-2024-005034
Humanin (HNG) · 5 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2403-N2129
- Report ID
- AX-2024-005034
- Compound
- Humanin (HNG)
- Compound class
- Metabolic and mitochondrial peptides
- Supplier
- GGPeps — Nantong Guangyuan Chemical Co., Ltd.
- Batch / lot
- GGPE-2403-N2129
- Declared label claim
- 5mg
- Laboratory
- Nordanalyt Laboratories
- Assay date
- 08 Apr 2024
- Submitted
- 20 Apr 2024
- Quarter
- 2024-Q2
- Submitter
- t.zielinski
- 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, 35 min gradient, 214 nm | 99.25 | % area | ≥ 97.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.75 | % area | ≤ 2.5 | PASS |
| Largest single impurity | RP-HPLC — deamidated (+1 Da) | 0.48 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 2685.3153 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 2685.3021 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -4.9 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 89.47 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 88.80 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 5.77 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 5.124 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 102.5 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.66 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.35 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.52 | % | — | 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 to pale-yellow 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 | 5.36 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 35 min gradient | 13.95 | min | 14.00 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.12 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 65,596 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs wild-type humanin (Ser14, −42 Da) | 0.78 | — | 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 | 13.95 | 4,823,858 | 99.25 | — |
| 2 | deamidated (+1 Da) | 13.62 | 23,329 | 0.48 | +0.984 |
| 3 | wild-type humanin (Ser14, −42 Da) | 13.77 | 5,832 | 0.12 | -42.011 |
| 4 | truncated (1-20) | 12.38 | 4,860 | 0.10 | -472.245 |
| 5 | Met sulfoxide (+16 Da) | 13.46 | 2,430 | 0.05 | +15.995 |
| 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 | 538.0677 | -0.0026 | 8.4 |
| 4+ | 672.3361 | 672.3328 | -0.0033 | 55.4 |
| 3+ | 896.1124 | 896.1080 | -0.0044 | 100.0 |
| 2+ | 1343.6649 | 1343.6583 | -0.0066 | 54.3 |
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 | 4.66 |
| Counter-ion (acetate) | ion chromatography | 5.35 |
| Residual solvent + inorganic residue | estimated | 0.52 |
| Total peptide content | by difference | 89.47 |
| 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) | 99.60 | 99.25 | divergence +0.38 pp vs batch median |
| Total impurities (% area) | 0.40 | 0.75 | |
| Largest single impurity (% area) | not stated | 0.48 | |
| Water (%) | not stated | 4.66 | |
| Counter-ion (%) | not stated | 5.35 | |
| Peptide content (%w/w) | not stated | 89.47 | |
| 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
- 08 Apr 2024
- Submitted to the index
- 20 Apr 2024
- 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 GGPE-2403-N2129 n=7
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-005032 | GGPE-2403-N2129 | PeptideMeter | 2024-Q2 | 99.93 | 4.13 | 94.2 | Supplier-supplied | 2 | FAIL |
| AX-2024-005033 | GGPE-2403-N2129 | Janoshik | 2024-Q2 | 99.22 | 3.41 | 103.6 | Supplier-supplied | 2 | FAIL |
| AX-2024-005035 | GGPE-2403-N2129 | Janoshik | 2024-Q2 | 99.62 | 3.66 | 93.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005036 | GGPE-2403-N2129 | PeptideMeter | 2024-Q2 | 99.13 | 4.27 | 93.5 | Buyer-sourced | 1 | MARGINAL |
| AX-2024-005037 | GGPE-2403-N2129 | Nordanalyt | 2024-Q2 | 99.15 | 4.21 | — | Supplier-supplied | 2 | FAIL |
| AX-2024-005038 | GGPE-2403-N2129 | Janoshik | 2024-Q2 | 98.96 | 4.04 | 99.2 | 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-2026-042737 | Selank | GGPE-2603-J9708 | Janoshik | 2026-Q3 | 98.40 | 9.14 | 97.4 | Buyer-sourced | 0 | FAIL |
| AX-2026-042804 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.50 | 7.97 | — | Supplier-supplied | 0 | FAIL |
| AX-2026-042803 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.48 | 8.01 | — | Laboratory-retained | 1 | FAIL |
| AX-2026-042802 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.74 | 7.09 | 96.0 | Supplier-supplied | 0 | FAIL |
| AX-2026-042796 | Selank | GGPE-2602-G2056 | Janoshik | 2026-Q3 | 98.26 | 7.56 | 97.5 | Buyer-sourced | 0 | FAIL |
| AX-2026-042648 | Melanotan II | GGPE-2603-P8735 | Janoshik | 2026-Q3 | 99.10 | 6.97 | — | Supplier-supplied | 4 | MARGINAL |
| AX-2026-042797 | Selank | GGPE-2602-G2056 | Medutest | 2026-Q3 | 98.46 | 7.92 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-042669 | CJC-1295 (no DAC) | GGPE-2606-E8495 | Medutest | 2026-Q3 | 98.61 | 4.06 | 95.5 | Supplier-supplied | 0 | PASS |