AX-2026-043529
MK-677 (Ibutamoren mesylate) · 500 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2511-G7276
FAILVERIFIED
- Report ID
- AX-2026-043529
- Compound
- MK-677 (Ibutamoren mesylate)
- Compound class
- Non-peptide adjuncts
- Supplier
- BCH — Bachem Holding (Suzhou) Co., Ltd.
- Batch / lot
- BCH-2511-G7276
- Declared label claim
- 500mg
- Laboratory
- Janoshik Analytical
- Assay date
- 02 May 2026
- Submitted
- 14 May 2026
- Quarter
- 2026-Q2
- Submitter
- l.rahimi
- 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, 30 min gradient, 214 nm | 98.35 | % area | ≥ 98.5 | FAIL |
| Total impurities | RP-HPLC, sum of reported peaks | 1.65 | % area | ≤ 1.5 | FAIL |
| Largest single impurity | RP-HPLC — spiroindane regioisomer | 1.03 | % area | ≤ 1.00 | FAIL |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 624.2181 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 624.2192 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +1.8 | ppm | ± 10 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 80.44 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 79.11 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 641.79 | mg | 500 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 507.720 | mg | 500 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 101.5 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.48 | % | ≤ 10.0 | PASS |
| Counter-ion (mesylate) | anion-exchange ion chromatography | 14.09 | % | ≤ 12.0 | FAIL |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.99 | % | — | 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 powder, no defined cake (melt-back) | — | white to off-white intact cake | FAIL |
| 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 | 4.27 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 13.93 | min | 13.86 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.86 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 86,203 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs free base (des-mesylate, −96 Da) | 0.21 | — | 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 | 13.93 | 4,780,115 | 98.35 | — |
| 2 | spiroindane regioisomer | 14.37 | 50,061 | 1.03 | 0.000 |
| 3 | free base (des-mesylate, −96 Da) | 13.97 | 18,469 | 0.38 | -96.011 |
| 4 | sulfonamide hydrolysis product (+18 Da) | 13.07 | 5,346 | 0.11 | +18.011 |
| 5 | residual DMF (process solvent) | 5.73 | 3,888 | 0.08 | -551.000 |
| 6 | O-desmethyl metabolite analogue (−14 Da) | 13.41 | 2,430 | 0.05 | -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 | 313.1169 | 0.0006 | 54.9 |
| 1+ | 625.2254 | 625.2265 | 0.0011 | 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 | 4.48 |
| Counter-ion (mesylate) | ion chromatography | 14.09 |
| Residual solvent + inorganic residue | estimated | 0.99 |
| Total peptide content | by difference | 80.44 |
| 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) | 98.61 | 98.35 | divergence +0.26 pp vs batch median |
| Total impurities (% area) | 1.39 | 1.65 | |
| Largest single impurity (% area) | 0.99 | 1.03 | |
| Water (%) | not stated | 4.48 | |
| Counter-ion (%) | not stated | 14.09 | |
| Peptide content (%w/w) | not stated | 80.44 | |
| Endotoxin (EU/mg) | 0.37 | 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
- 02 May 2026
- Submitted to the index
- 14 May 2026
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 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 BCH-2511-G7276 n=13
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043521 | BCH-2511-G7276 | Medutest | 2026-Q2 | 98.43 | 4.78 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-043522 | BCH-2511-G7276 | Janoshik | 2026-Q2 | 98.13 | 4.21 | 96.8 | Supplier-supplied | 1 | FAIL |
| AX-2026-043523 | BCH-2511-G7276 | Janoshik | 2026-Q2 | 98.21 | 4.31 | — | Supplier-supplied | 1 | FAIL |
| AX-2026-043524 | BCH-2511-G7276 | Janoshik | 2026-Q2 | 98.36 | 4.68 | — | Supplier-supplied | 1 | FAIL |
| AX-2026-043525 | BCH-2511-G7276 | Medutest | 2026-Q2 | 98.37 | 4.32 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-043526 | BCH-2511-G7276 | Medutest | 2026-Q2 | 97.60 | 4.50 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-043527 | BCH-2511-G7276 | Janoshik | 2026-Q2 | 98.35 | 4.36 | 95.5 | Supplier-supplied | 1 | FAIL |
| AX-2026-043528 | BCH-2511-G7276 | Janoshik | 2026-Q2 | 98.35 | 4.90 | — | Supplier-supplied | 1 | FAIL |
| AX-2026-043530 | BCH-2511-G7276 | PeptideMeter | 2026-Q2 | 98.55 | 4.28 | 88.8 | Supplier-supplied | 2 | FAIL |
| AX-2026-043531 | BCH-2511-G7276 | Janoshik | 2026-Q2 | 98.59 | 4.34 | — | Supplier-supplied | 1 | FAIL |
| AX-2026-043532 | BCH-2511-G7276 | Janoshik | 2026-Q2 | 98.18 | 4.32 | — | Laboratory-retained | 1 | FAIL |
| AX-2026-043533 | BCH-2511-G7276 | VendorInvestigate | 2026-Q2 | 97.96 | 5.07 | — | Buyer-sourced | 1 | FAIL |
Cross-sections
| 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-2026-043574 | N-Acetyl Semax Amide | BCH-2602-E8253 | Janoshik | 2026-Q3 | 97.75 | 8.85 | 97.9 | Supplier-supplied | 1 | FAIL |
| AX-2026-043503 | BPC-157 | BCH-2603-G6422 | Janoshik | 2026-Q3 | 98.46 | 4.32 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043575 | N-Acetyl Semax Amide | BCH-2602-E8253 | Janoshik | 2026-Q3 | 97.44 | 9.19 | 104.8 | Supplier-supplied | 1 | FAIL |
| AX-2026-043539 | CJC-1295 with DAC | BCH-2607-H7307 | Janoshik | 2026-Q3 | 98.12 | 5.78 | 100.6 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043504 | BPC-157 | BCH-2603-G6422 | Janoshik | 2026-Q3 | 98.38 | 4.45 | 95.5 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043502 | BPC-157 | BCH-2603-G6422 | PeptideMeter | 2026-Q3 | 97.72 | 4.86 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-043501 | BPC-157 | BCH-2603-G6422 | PeptideMeter | 2026-Q3 | 98.37 | 4.75 | 100.8 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043573 | N-Acetyl Semax Amide | BCH-2602-E8253 | Janoshik | 2026-Q3 | 97.47 | 8.59 | — | Supplier-supplied | 1 | FAIL |