AX-2025-020021
MOTS-c · 10 mg declared · Shanghai ERP Biotechnology Co., Ltd. · lot ERP-2508-M7270
- Report ID
- AX-2025-020021
- Compound
- MOTS-c
- Compound class
- Metabolic and mitochondrial peptides
- Supplier
- ERP — Shanghai ERP Biotechnology Co., Ltd.
- Batch / lot
- ERP-2508-M7270
- Declared label claim
- 10mg
- Laboratory
- PeptideMeter
- Assay date
- 02 Sep 2025
- Submitted
- 18 Sep 2025
- Quarter
- 2025-Q3
- Submitter
- Contributor #B-5903
- 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, 28 min gradient, 214 nm | 99.36 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.64 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — Met1 sulfoxide (+16 Da) | 0.26 | % 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 | 92.71 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 92.12 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 11.45 | mg | 10 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 10.548 | mg | 10 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 105.5 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 2.36 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 4.18 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.75 | % | — | 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 | 5.30 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 9.76 | min | 9.78 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.06 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 47,687 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs des-Met1 (−131 Da) | 1.12 | — | 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 | MOTS-c — main peak | 9.76 | 4,829,204 | 99.36 | — |
| 2 | Met1 sulfoxide (+16 Da) | 9.41 | 12,637 | 0.26 | +15.995 |
| 3 | bis-sulfoxide (+32 Da) | 9.14 | 11,179 | 0.23 | +31.990 |
| 4 | des-Met1 (−131 Da) | 9.97 | 4,374 | 0.09 | -131.040 |
| 5 | deamidated (+1 Da) | 9.48 | 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 | 2.36 |
| Counter-ion (acetate) | ion chromatography | 4.18 |
| Residual solvent + inorganic residue | estimated | 0.75 |
| Total peptide content | by difference | 92.71 |
| 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) | 98.93 | 99.36 | divergence +0.16 pp vs batch median |
| Total impurities (% area) | 1.07 | 0.64 | |
| Largest single impurity (% area) | 0.47 | 0.26 | |
| Water (%) | 1.2 | 2.36 | |
| Counter-ion (%) | 5.5 | 4.18 | |
| Peptide content (%w/w) | 92.7 | 92.71 | |
| Endotoxin (EU/mg) | 0.24 | 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, 12 d) → assay. Submitter did not handle the vial.
- Assay date
- 02 Sep 2025
- Submitted to the index
- 18 Sep 2025
- 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 ERP-2508-M7270 n=3
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-020020 | ERP-2508-M7270 | Medutest | 2025-Q3 | 98.77 | 1.89 | 107.0 | Supplier-supplied | 0 | PASS |
| AX-2025-020022 | ERP-2508-M7270 | Kestrel | 2025-Q3 | 98.57 | 1.46 | 101.9 | Supplier-supplied | 1 | MARGINAL |
Cross-sections
- All MOTS-c records n=112
- All ERP records n=247
- All PeptideMeter records n=1107
- All 2025-Q3 records n=819
- MOTS-c by supplier
- MOTS-c impurity profile
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041952 | TFC | TFC-2605-R4770 | PeptideMeter | 2026-Q2 | 99.65 | 5.60 | 95.5 | Supplier-supplied | 0 | PASS |
| AX-2026-043416 | WXT | WXT-2511-P4848 | Janoshik | 2026-Q2 | 98.23 | 5.14 | 106.7 | Supplier-supplied | 0 | PASS |
| AX-2026-043149 | SSA | SSA-2511-W7415 | Janoshik | 2026-Q2 | 98.00 | 5.42 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043498 | BCH | BCH-2511-L5815 | Janoshik | 2026-Q2 | 96.96 | 3.75 | 93.4 | Supplier-supplied | 0 | FAIL |
| AX-2026-043150 | SSA | SSA-2511-W7415 | Janoshik | 2026-Q2 | 98.33 | 5.76 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043152 | SSA | SSA-2511-W7415 | Janoshik | 2026-Q2 | 98.64 | 5.48 | 88.9 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-041953 | TFC | TFC-2605-R4770 | Janoshik | 2026-Q2 | 99.72 | 5.27 | 90.8 | Supplier-supplied | 2 | FAIL |
| AX-2026-043153 | SSA | SSA-2511-W7415 | Medutest | 2026-Q2 | 98.78 | 5.52 | — | Supplier-supplied | 0 | PASS |
| 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 |