AX-2026-043558
MK-677 (Ibutamoren mesylate) · 500 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2601-G7069
FAILIDENTITY CONSISTENT
- Report ID
- AX-2026-043558
- Compound
- MK-677 (Ibutamoren mesylate)
- Compound class
- Non-peptide adjuncts
- Supplier
- BCH — Bachem Holding (Suzhou) Co., Ltd.
- Batch / lot
- BCH-2601-G7069
- Declared label claim
- 500mg
- Laboratory
- PeptideMeter
- Assay date
- 16 Feb 2026
- Submitted
- 10 Mar 2026
- Quarter
- 2026-Q1
- Submitter
- s.lindholm
- 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 | 97.63 | % area | ≥ 98.5 | FAIL |
| Total impurities | RP-HPLC, sum of reported peaks | 2.37 | % area | ≤ 1.5 | FAIL |
| Largest single impurity | RP-HPLC — O-desmethyl metabolite analogue (−14 Da) | 1.07 | % 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) | 624.2177 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -0.7 | ppm | ± 10 | PASS |
| Peptide content | not ordered on this submission | not determined | — | required to check label claim | NOT TESTED |
| Water content | Karl Fischer, coulometric, duplicate | 3.64 | % | ≤ 10.0 | PASS |
| Counter-ion (mesylate) | anion-exchange ion chromatography | 15.26 | % | ≤ 12.0 | FAIL |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.72 | % | — | 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, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 4.79 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 13.00 | min | 13.01 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.89 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 76,794 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs free base (des-mesylate, −96 Da) | 0.19 | — | 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 | 13.00 | 4,745,121 | 97.63 | — |
| 2 | O-desmethyl metabolite analogue (−14 Da) | 12.51 | 52,005 | 1.07 | -14.016 |
| 3 | spiroindane regioisomer | 13.41 | 26,246 | 0.54 | 0.000 |
| 4 | free base (des-mesylate, −96 Da) | 13.04 | 15,067 | 0.31 | -96.011 |
| 5 | sulfonamide hydrolysis product (+18 Da) | 12.20 | 11,179 | 0.23 | +18.011 |
| 6 | residual DMF (process solvent) | 5.35 | 10,693 | 0.22 | -551.000 |
| 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 | 313.1161 | -0.0002 | 59.6 |
| 1+ | 625.2254 | 625.2250 | -0.0004 | 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.
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) | 98.28 | 97.63 | divergence +0.35 pp vs batch median |
| Total impurities (% area) | 1.72 | 2.37 | |
| Largest single impurity (% area) | not stated | 1.07 | |
| Water (%) | not stated | 3.64 | |
| Counter-ion (%) | not stated | 15.26 | |
| Peptide content (%w/w) | not stated | not determined | |
| Endotoxin (EU/mg) | not stated | not determined | |
| Method stated on certificate | NO | — | no method section — the result cannot be reconciled against any other |
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, 4 d) → assay. Submitter did not handle the vial.
- Assay date
- 16 Feb 2026
- Submitted to the index
- 10 Mar 2026
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- IDENTITY CONSISTENT
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-2601-G7069 n=14
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043545 | BCH-2601-G7069 | Janoshik | 2026-Q1 | 98.02 | 4.02 | 96.7 | Supplier-supplied | 1 | FAIL |
| AX-2026-043546 | BCH-2601-G7069 | VendorInvestigate | 2026-Q1 | 97.10 | 4.43 | 98.3 | Buyer-sourced | 1 | FAIL |
| AX-2026-043547 | BCH-2601-G7069 | PeptideMeter | 2026-Q1 | 98.33 | 3.67 | — | Supplier-supplied | 1 | FAIL |
| AX-2026-043548 | BCH-2601-G7069 | VendorInvestigate | 2026-Q1 | 97.96 | 3.64 | 103.3 | Buyer-sourced | 1 | FAIL |
| AX-2026-043549 | BCH-2601-G7069 | Janoshik | 2026-Q1 | 97.89 | 4.72 | — | Supplier-supplied | 1 | FAIL |
| AX-2026-043550 | BCH-2601-G7069 | PeptideMeter | 2026-Q1 | 97.71 | 3.58 | 98.3 | Buyer-sourced | 1 | FAIL |
| AX-2026-043551 | BCH-2601-G7069 | Janoshik | 2026-Q1 | 98.19 | 3.36 | 106.5 | Supplier-supplied | 1 | FAIL |
| AX-2026-043552 | BCH-2601-G7069 | VendorInvestigate | 2026-Q1 | 97.39 | 4.34 | 96.1 | Buyer-sourced | 1 | FAIL |
| AX-2026-043553 | BCH-2601-G7069 | Nordanalyt | 2026-Q1 | 98.01 | 3.91 | — | Supplier-supplied | 1 | FAIL |
| AX-2026-043554 | BCH-2601-G7069 | Kestrel | 2026-Q1 | 98.39 | 4.06 | 90.4 | Supplier-supplied | 2 | FAIL |
| AX-2026-043555 | BCH-2601-G7069 | Janoshik | 2026-Q1 | 97.36 | 3.41 | 104.8 | Supplier-supplied | 1 | FAIL |
| AX-2026-043556 | BCH-2601-G7069 | Janoshik | 2026-Q1 | 98.30 | 3.61 | 88.8 | Supplier-supplied | 2 | FAIL |
| AX-2026-043557 | BCH-2601-G7069 | Janoshik | 2026-Q1 | 97.47 | 4.26 | 93.4 | Buyer-sourced | 1 | 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-2026-043574 | 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 |