AX-2025-020682
MK-677 (Ibutamoren mesylate) · 500 mg declared · GL Biochem (Shanghai) Ltd. · lot GLBI-2501-Y8359
FAILVERIFIED
- Report ID
- AX-2025-020682
- Compound
- MK-677 (Ibutamoren mesylate)
- Compound class
- Non-peptide adjuncts
- Supplier
- GL Biochem — GL Biochem (Shanghai) Ltd.
- Batch / lot
- GLBI-2501-Y8359
- Declared label claim
- 500mg
- Laboratory
- PeptideMeter
- Assay date
- 12 Jun 2025
- Submitted
- 23 Jun 2025
- Quarter
- 2025-Q2
- Submitter
- k.mensa
- Sample provenance
- Supplier-supplied
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, 28 min gradient, 214 nm | 98.80 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.20 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — free base (des-mesylate, −96 Da) | 0.71 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 624.2181 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 624.2209 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +4.5 | ppm | ± 10 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 80.89 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 79.92 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 623.79 | mg | 500 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 498.533 | mg | 500 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 99.7 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 5.36 | % | ≤ 10.0 | PASS |
| Counter-ion (mesylate) | anion-exchange ion chromatography | 12.75 | % | ≤ 12.0 | FAIL |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 1.00 | % | — | 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, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 5.41 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 13.02 | min | 13.01 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.00 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 67,340 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs free base (des-mesylate, −96 Da) | 0.18 | — | 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 | 13.02 | 4,801,986 | 98.80 | — |
| 2 | free base (des-mesylate, −96 Da) | 13.06 | 34,508 | 0.71 | -96.011 |
| 3 | sulfonamide hydrolysis product (+18 Da) | 12.22 | 15,067 | 0.31 | +18.011 |
| 4 | spiroindane regioisomer | 13.43 | 4,374 | 0.09 | 0.000 |
| 5 | residual DMF (process solvent) | 5.37 | 2,430 | 0.05 | -551.000 |
| 6 | O-desmethyl metabolite analogue (−14 Da) | 12.53 | 1,944 | 0.04 | -14.016 |
| 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 3
Mass spectrum and identity
Theoretical monoisotopic mass 624.2181 Da, computed from C27H36N4O5S · CH4O3S. 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 (%) |
|---|---|---|---|---|
| 2+ | 313.1163 | 313.1177 | 0.0014 | 56.7 |
| 1+ | 625.2254 | 625.2282 | 0.0028 | 100.0 |
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 | 5.36 |
| Counter-ion (mesylate) | ion chromatography | 12.75 |
| Residual solvent + inorganic residue | estimated | 1.00 |
| Total peptide content | by difference | 80.89 |
| 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) | 99.0 | 98.80 | divergence +0.48 pp vs batch median |
| Total impurities (% area) | 1.00 | 1.20 | |
| Largest single impurity (% area) | not stated | 0.71 | |
| Water (%) | 3.5 | 5.36 | |
| Counter-ion (%) | not stated | 12.75 | |
| Peptide content (%w/w) | not stated | 80.89 | |
| 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
- 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
- 12 Jun 2025
- Submitted to the index
- 23 Jun 2025
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- VERIFIED
Section 6
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Section 7
Related records
Same batch — lot GLBI-2501-Y8359 n=13
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-020674 | GLBI-2501-Y8359 | Medutest | 2025-Q2 | 98.53 | 5.40 | 99.0 | Supplier-supplied | 3 | FAIL |
| AX-2025-020675 | GLBI-2501-Y8359 | PeptideMeter | 2025-Q2 | 97.87 | 5.64 | 99.9 | Supplier-supplied | 3 | FAIL |
| AX-2025-020676 | GLBI-2501-Y8359 | Janoshik | 2025-Q2 | 98.48 | 4.62 | 90.6 | Supplier-supplied | 3 | FAIL |
| AX-2025-020677 | GLBI-2501-Y8359 | Janoshik | 2025-Q2 | 99.01 | 5.05 | 92.8 | Supplier-supplied | 3 | FAIL |
| AX-2025-020678 | GLBI-2501-Y8359 | VendorInvestigate | 2025-Q2 | 98.26 | 5.12 | 93.7 | Buyer-sourced | 4 | FAIL |
| AX-2025-020679 | GLBI-2501-Y8359 | Janoshik | 2025-Q2 | 98.52 | 4.88 | 106.1 | Supplier-supplied | 3 | FAIL |
| AX-2025-020680 | GLBI-2501-Y8359 | Janoshik | 2025-Q2 | 98.72 | 5.10 | — | Supplier-supplied | 3 | FAIL |
| AX-2025-020681 | GLBI-2501-Y8359 | PeptideMeter | 2025-Q2 | 98.23 | 5.69 | — | Buyer-sourced | 3 | FAIL |
| AX-2025-020683 | GLBI-2501-Y8359 | VendorInvestigate | 2025-Q2 | 98.26 | 5.67 | 102.2 | Buyer-sourced | 3 | FAIL |
| AX-2025-020684 | GLBI-2501-Y8359 | Medutest | 2025-Q2 | 99.10 | 5.46 | 92.3 | Supplier-supplied | 3 | FAIL |
| AX-2025-020685 | GLBI-2501-Y8359 | PeptideMeter | 2025-Q2 | 98.54 | 5.17 | — | Supplier-supplied | 3 | FAIL |
| AX-2025-020686 | GLBI-2501-Y8359 | VendorInvestigate | 2025-Q2 | 98.24 | 4.66 | — | Buyer-sourced | 3 | FAIL |
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043524 | BCH | BCH-2511-G7276 | Janoshik | 2026-Q2 | 98.36 | 4.68 | — | Supplier-supplied | 1 | FAIL |
| AX-2026-041764 | FGP | FGP-2604-K1470 | Janoshik | 2026-Q2 | 99.93 | 5.34 | — | Supplier-supplied | 1 | FAIL |
| AX-2026-043527 | BCH | BCH-2511-G7276 | Janoshik | 2026-Q2 | 98.35 | 4.36 | 95.5 | Supplier-supplied | 1 | FAIL |
| AX-2026-042409 | SWB | SWB-2605-B4738 | Medutest | 2026-Q2 | 99.32 | 2.99 | 94.9 | Laboratory-retained | 1 | FAIL |
| AX-2026-043526 | BCH | BCH-2511-G7276 | Medutest | 2026-Q2 | 97.60 | 4.50 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-042410 | SWB | SWB-2605-B4738 | Janoshik | 2026-Q2 | 99.61 | 2.81 | — | Supplier-supplied | 1 | FAIL |
| AX-2026-041765 | FGP | FGP-2604-K1470 | Janoshik | 2026-Q2 | 99.93 | 5.08 | — | Supplier-supplied | 0 | FAIL |
| AX-2026-043525 | BCH | BCH-2511-G7276 | Medutest | 2026-Q2 | 98.37 | 4.32 | — | Buyer-sourced | 1 | FAIL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043176 | Kisspeptin-10 | GLBI-2608-N8085 | Medutest | 2026-Q3 | 98.22 | 3.30 | 92.5 | Buyer-sourced | 2 | FAIL |
| AX-2026-043180 | Kisspeptin-10 | GLBI-2608-N8085 | Janoshik | 2026-Q3 | 98.69 | 3.37 | 103.8 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043178 | Kisspeptin-10 | GLBI-2608-N8085 | Janoshik | 2026-Q3 | 98.24 | 4.44 | 96.0 | Supplier-supplied | 2 | FAIL |
| AX-2026-043177 | Kisspeptin-10 | GLBI-2608-N8085 | Janoshik | 2026-Q3 | 98.31 | 3.87 | 106.5 | Buyer-sourced | 2 | FAIL |
| AX-2026-043202 | Semaglutide | GLBI-2602-U8631 | PeptideMeter | 2026-Q3 | 96.77 | 6.38 | 89.7 | Supplier-supplied | 3 | FAIL |
| AX-2026-043174 | Kisspeptin-10 | GLBI-2608-N8085 | Medutest | 2026-Q3 | 98.18 | 4.09 | — | Laboratory-retained | 2 | FAIL |
| AX-2026-043201 | Semaglutide | GLBI-2602-U8631 | Janoshik | 2026-Q3 | 96.91 | 5.77 | 91.2 | Supplier-supplied | 2 | FAIL |
| AX-2026-043203 | Semaglutide | GLBI-2602-U8631 | Medutest | 2026-Q3 | 97.45 | 6.09 | — | Supplier-supplied | 2 | MARGINAL |