AX-2026-043431
MOTS-c · 5 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2512-K4589
- Report ID
- AX-2026-043431
- Compound
- MOTS-c
- Compound class
- Metabolic and mitochondrial peptides
- Supplier
- WXT — WuXi TIDES (WuXi AppTec Testing Division)
- Batch / lot
- WXT-2512-K4589
- Declared label claim
- 5mg
- Laboratory
- Janoshik Analytical
- Assay date
- 12 Mar 2026
- Submitted
- 28 Mar 2026
- Quarter
- 2026-Q1
- Submitter
- Contributor #D-1163
- 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, 30 min gradient, 214 nm | 98.81 | % area | ≥ 98.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.19 | % area | ≤ 2.0 | PASS |
| Largest single impurity | RP-HPLC — Met1 sulfoxide (+16 Da) | 0.53 | % 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 | 93.02 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 91.91 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 4.99 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 4.586 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 91.7 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 2.12 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 4.44 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.42 | % | — | 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 | 4.70 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 10.50 | min | 10.42 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.09 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 72,922 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs des-Met1 (−131 Da) | 1.38 | — | 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 | 10.50 | 4,802,472 | 98.81 | — |
| 2 | Met1 sulfoxide (+16 Da) | 10.12 | 25,760 | 0.53 | +15.995 |
| 3 | bis-sulfoxide (+32 Da) | 9.84 | 18,469 | 0.38 | +31.990 |
| 4 | des-Met1 (−131 Da) | 10.72 | 9,235 | 0.19 | -131.040 |
| 5 | deamidated (+1 Da) | 10.20 | 4,374 | 0.09 | +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 | 2.12 |
| Counter-ion (acetate) | ion chromatography | 4.44 |
| Residual solvent + inorganic residue | estimated | 0.42 |
| Total peptide content | by difference | 93.02 |
| 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) | 98.0 | 98.81 | divergence +0.08 pp vs batch median |
| Total impurities (% area) | not stated | 1.19 | |
| Largest single impurity (% area) | not stated | 0.53 | |
| Water (%) | not stated | 2.12 | |
| Counter-ion (%) | not stated | 4.44 | |
| Peptide content (%w/w) | not stated | 93.02 | |
| Endotoxin (EU/mg) | 1.47 | 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
- 12 Mar 2026
- Submitted to the index
- 28 Mar 2026
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 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 WXT-2512-K4589 n=3
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043430 | WXT-2512-K4589 | Janoshik | 2026-Q1 | 97.64 | 1.40 | 101.6 | Supplier-supplied | 1 | FAIL |
| AX-2026-043432 | WXT-2512-K4589 | Janoshik | 2026-Q1 | 97.92 | 2.47 | 90.0 | Supplier-supplied | 1 | FAIL |
Cross-sections
- All MOTS-c records n=112
- All WXT records n=353
- All Janoshik records n=3159
- All 2026-Q1 records n=832
- 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-2026-043488 | Pramlintide | WXT-2603-D6052 | Janoshik | 2026-Q3 | 97.87 | 4.37 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043406 | Semaglutide | WXT-2604-C4728 | Janoshik | 2026-Q3 | 97.24 | 4.65 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043421 | Sermorelin | WXT-2608-P4867 | Janoshik | 2026-Q3 | 98.15 | 3.09 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043420 | Sermorelin | WXT-2608-P4867 | Medutest | 2026-Q3 | 98.62 | 3.07 | 96.4 | Supplier-supplied | 0 | PASS |
| AX-2026-043423 | Sermorelin | WXT-2608-P4867 | Janoshik | 2026-Q3 | 98.28 | 3.86 | 98.5 | Buyer-sourced | 0 | PASS |
| AX-2026-043401 | Semaglutide | WXT-2604-C4728 | Medutest | 2026-Q3 | 97.70 | 4.78 | 91.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043400 | Semaglutide | WXT-2604-C4728 | Nordanalyt | 2026-Q3 | 96.86 | 4.11 | 106.4 | Laboratory-retained | 1 | FAIL |
| AX-2026-043422 | Sermorelin | WXT-2608-P4867 | Medutest | 2026-Q3 | 98.35 | 3.59 | — | Supplier-supplied | 1 | MARGINAL |