99.72 % on MK-677 (Ibutamoren mesylate) sits at the top of what this index sees. Read it with the method: Medutest ran a 25 min gradient here, and the compound fingerprint names a mass-identical species that a shorter run folds into the main peak. On this gradient the figure is well founded.
AX-2025-020902
MK-677 (Ibutamoren mesylate) · 1000 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2502-F2050
FAILPURITY ONLY
- Report ID
- AX-2025-020902
- Compound
- MK-677 (Ibutamoren mesylate)
- Compound class
- Non-peptide adjuncts
- Supplier
- WXT — WuXi TIDES (WuXi AppTec Testing Division)
- Batch / lot
- WXT-2502-F2050
- Declared label claim
- 1000mg
- Laboratory
- Medutest
- Assay date
- 24 Mar 2025
- Submitted
- 18 Apr 2025
- Quarter
- 2025-Q1
- Submitter
- h.batista
- Sample provenance
- Buyer-sourced
Section 1
Results
Measured against the index acceptance specification for the non-peptide adjuncts 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 | 99.72 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.28 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — residual DMF (process solvent) | 0.19 | % 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 | 79.45 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 79.23 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 1348.25 | mg | 1000 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 1068.218 | mg | 1000 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 106.8 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.14 | % | ≤ 10.0 | PASS |
| Counter-ion (mesylate) | anion-exchange ion chromatography | 16.04 | % | ≤ 12.0 | FAIL |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.37 | % | — | NOT TESTED |
| Endotoxin | not ordered on this submission | not determined | — | ≤ 5.0 | NOT TESTED |
| Sterility | membrane filtration, USP <71>, 14 d | No growth at 14 d | — | no growth | PASS |
| 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 with a single visible fibre | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 4.68 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 11.91 | min | 11.73 ± 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 | 60,956 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs free base (des-mesylate, −96 Da) | 0.17 | — | no index criterion | REPORTED |
Section 2
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 | MK-677 (Ibutamoren mesylate) — main peak | 11.91 | 4,846,701 | 99.72 | — |
| 2 | residual DMF (process solvent) | 5.08 | 9,235 | 0.19 | -551.000 |
| 3 | spiroindane regioisomer | 12.28 | 2,430 | 0.05 | 0.000 |
| 4 | free base (des-mesylate, −96 Da) | 11.94 | 972 | 0.02 | -96.011 |
| 5 | sulfonamide hydrolysis product (+18 Da) | 11.19 | 972 | 0.02 | +18.011 |
| 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.
Section 4
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 | 4.14 |
| Counter-ion (mesylate) | ion chromatography | 16.04 |
| Residual solvent + inorganic residue | estimated | 0.37 |
| Total peptide content | by difference | 79.45 |
| 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) | 99.82 | 99.72 | divergence +0.21 pp vs batch median |
| Total impurities (% area) | 0.18 | 0.28 | |
| Largest single impurity (% area) | 0.11 | 0.19 | |
| Water (%) | 2.4 | 4.14 | |
| Counter-ion (%) | not stated | 16.04 | |
| Peptide content (%w/w) | not stated | 79.45 | |
| Endotoxin (EU/mg) | not stated | not determined | |
| Method stated on certificate | YES | — | column, gradient and wavelength given |
Section 5
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
- Buyer-sourced
- Evidentiary weight
- Strongest available evidence in this index.
- Chain of custody
- Retail purchase → submitter (2–8 °C, 15 d) → laboratory (courier, ambient, 11 d) → assay.
- Assay date
- 24 Mar 2025
- Submitted to the index
- 18 Apr 2025
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- PURITY ONLY
Section 6
Annotations 3
Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.
Plate count on this run supports the separation claimed. A high purity figure from an inefficient column is a merged peak reported as a clean one; that is not what happened here.
Strong provenance does not fix small n. One well-sourced record is still one record, and the batch page says how many others exist for WXT-2502-F2050.
Section 7
Related records
Same batch — lot WXT-2502-F2050 n=8
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-020897 | WXT-2502-F2050 | Janoshik | 2025-Q1 | 99.20 | 4.39 | 91.7 | Buyer-sourced | 1 | FAIL |
| AX-2025-020898 | WXT-2502-F2050 | PeptideMeter | 2025-Q1 | 99.64 | 4.40 | — | Buyer-sourced | 0 | FAIL |
| AX-2025-020899 | WXT-2502-F2050 | VendorInvestigate | 2025-Q1 | 99.59 | 4.78 | — | Buyer-sourced | 1 | FAIL |
| AX-2025-020900 | WXT-2502-F2050 | PeptideMeter | 2025-Q1 | 99.48 | 4.33 | 90.2 | Buyer-sourced | 0 | FAIL |
| AX-2025-020901 | WXT-2502-F2050 | Janoshik | 2025-Q1 | 99.45 | 4.41 | — | Buyer-sourced | 0 | FAIL |
| AX-2025-020903 | WXT-2502-F2050 | Janoshik | 2025-Q1 | 99.62 | 4.12 | 100.8 | Buyer-sourced | 0 | FAIL |
| AX-2025-020904 | WXT-2502-F2050 | Janoshik | 2025-Q1 | 99.70 | 4.69 | 101.0 | Buyer-sourced | 0 | FAIL |
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041633 | FGP | FGP-2604-K8509 | PeptideMeter | 2026-Q2 | 99.81 | 4.91 | 96.2 | Buyer-sourced | 0 | FAIL |
| AX-2026-041733 | TFS | TFS-{CAT}-1096 | PeptideMeter | 2026-Q2 | 99.07 | 3.93 | 95.1 | Laboratory-retained | 0 | FAIL |
| AX-2026-043468 | BCH | BCH-2511-G5204 | Medutest | 2026-Q2 | 98.85 | 4.30 | 96.5 | Buyer-sourced | 1 | FAIL |
| AX-2026-042647 | SWB | SWB-2605-B7365 | Nordanalyt | 2026-Q2 | 99.28 | 2.86 | 93.1 | Buyer-sourced | 0 | FAIL |
| AX-2026-041634 | FGP | FGP-2604-K8509 | PeptideMeter | 2026-Q2 | 99.86 | 5.17 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043469 | BCH | BCH-2511-G5204 | Medutest | 2026-Q2 | 98.51 | 4.86 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-042648 | SWB | SWB-2605-B7365 | Janoshik | 2026-Q2 | 99.93 | 2.60 | 96.9 | Supplier-supplied | 0 | FAIL |
| AX-2026-041732 | TFS | TFS-{CAT}-1096 | Janoshik | 2026-Q2 | 99.48 | 3.16 | 106.4 | Buyer-sourced | 0 | FAIL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043376 | Semaglutide | WXT-2604-C3248 | Janoshik | 2026-Q3 | 97.08 | 4.22 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043429 | L-Glutathione (reduced) | WXT-2605-B3833 | Nordanalyt | 2026-Q3 | 98.48 | 6.58 | 96.9 | Supplier-supplied | 1 | FAIL |
| AX-2026-043347 | Leuprolide | WXT-2604-K2596 | PeptideMeter | 2026-Q3 | 99.16 | 5.99 | 93.6 | Buyer-sourced | 0 | PASS |
| AX-2026-043353 | Leuprolide | WXT-2604-K2596 | Janoshik | 2026-Q3 | 99.19 | 4.90 | 95.3 | Laboratory-retained | 0 | PASS |
| AX-2026-043345 | Leuprolide | WXT-2604-K2596 | Janoshik | 2026-Q3 | 98.93 | 5.28 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043424 | L-Glutathione (reduced) | WXT-2605-B3833 | PeptideMeter | 2026-Q3 | 98.37 | 6.86 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043374 | Semaglutide | WXT-2604-C3248 | Janoshik | 2026-Q3 | 97.00 | 3.56 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043377 | Semaglutide | WXT-2604-C3248 | PeptideMeter | 2026-Q3 | 97.20 | 4.08 | — | Buyer-sourced | 1 | MARGINAL |