Photodiode-array spectral homogeneity across the main peak would convert 99.79 % from a good number into a checked one. It is a free measurement on any instrument that already has the detector.
AX-2025-018647
MK-677 (Ibutamoren mesylate) · 1000 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2507-F5673
FAILPURITY ONLY
- Report ID
- AX-2025-018647
- Compound
- MK-677 (Ibutamoren mesylate)
- Compound class
- Non-peptide adjuncts
- Supplier
- QSC — Qingdao Sigma Chemical Co., Ltd.
- Batch / lot
- QSC-2507-F5673
- Declared label claim
- 1000mg
- Laboratory
- PeptideMeter
- Assay date
- 15 Jul 2025
- Submitted
- 25 Jul 2025
- Quarter
- 2025-Q3
- Submitter
- h.wikstrom
- 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, 28 min gradient, 214 nm | 99.79 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.21 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — sulfonamide hydrolysis product (+18 Da) | 0.10 | % area | ≤ 1.00 | PASS |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Peptide content | not ordered on this submission | not determined | — | required to check label claim | NOT TESTED |
| Water content | Karl Fischer, coulometric, duplicate | 4.29 | % | ≤ 10.0 | PASS |
| Counter-ion (mesylate) | anion-exchange ion chromatography | 12.82 | % | ≤ 12.0 | FAIL |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.14 | % | — | 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 to pale-yellow 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 | 5.03 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 13.04 | min | 13.01 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.95 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 60,541 | — | ≥ 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 | 13.04 | 4,850,103 | 99.79 | — |
| 2 | sulfonamide hydrolysis product (+18 Da) | 12.24 | 4,860 | 0.10 | +18.011 |
| 3 | free base (des-mesylate, −96 Da) | 13.08 | 3,402 | 0.07 | -96.011 |
| 4 | spiroindane regioisomer | 13.45 | 1,944 | 0.04 | 0.000 |
| 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 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) | 99.90 | 99.79 | divergence +0.16 pp vs batch median |
| Total impurities (% area) | 0.10 | 0.21 | |
| Largest single impurity (% area) | 0.06 | 0.10 | |
| Water (%) | 4.2 | 4.29 | |
| Counter-ion (%) | 3.3 | 12.82 | |
| Peptide content (%w/w) | 97.9 | not determined | |
| 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 (ambient, 10 d) → laboratory (courier, cold pack, 8 d) → assay.
- Assay date
- 15 Jul 2025
- Submitted to the index
- 25 Jul 2025
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Section 6
Annotations 5
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.
Stated storage conditions on the certificate against the observed transit conditions in the custody block: on this record they agree, which removes one class of explanation for anything unexpected.
Where two laboratories tested the same retail lot, the paired difference is a clean estimate of inter-lab bias with no selection term in it at all. Those pairs are the backbone of the agreement analysis.
Resolution to the nearest named impurity is reported on this record with no verdict attached, which is the correct handling. A threshold on that figure would penalise compounds for their own impurity profiles.
Worth flagging to whoever submits next on this lot.
Section 7
Related records
Same batch — lot QSC-2507-F5673 n=11
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-018646 | QSC-2507-F5673 | Kestrel | 2025-Q3 | 99.65 | 4.78 | — | Buyer-sourced | 1 | FAIL |
| AX-2025-018648 | QSC-2507-F5673 | Janoshik | 2025-Q3 | 99.72 | 4.26 | — | Buyer-sourced | 1 | FAIL |
| AX-2025-018649 | QSC-2507-F5673 | Nordanalyt | 2025-Q3 | 99.79 | 4.54 | 107.3 | Laboratory-retained | 1 | FAIL |
| AX-2025-018650 | QSC-2507-F5673 | Janoshik | 2025-Q3 | 99.61 | 4.34 | — | Buyer-sourced | 1 | FAIL |
| AX-2025-018651 | QSC-2507-F5673 | Janoshik | 2025-Q3 | 99.74 | 4.21 | 99.5 | Laboratory-retained | 1 | FAIL |
| AX-2025-018652 | QSC-2507-F5673 | Janoshik | 2025-Q3 | 99.52 | 4.27 | — | Buyer-sourced | 1 | FAIL |
| AX-2025-018653 | QSC-2507-F5673 | Nordanalyt | 2025-Q3 | 99.87 | 4.46 | 94.9 | Buyer-sourced | 1 | FAIL |
| AX-2025-018654 | QSC-2507-F5673 | PeptideMeter | 2025-Q3 | 99.79 | 4.78 | 105.4 | Buyer-sourced | 1 | FAIL |
| AX-2025-018655 | QSC-2507-F5673 | Janoshik | 2025-Q3 | 99.78 | 4.37 | 94.8 | Buyer-sourced | 1 | FAIL |
| AX-2025-018656 | QSC-2507-F5673 | Janoshik | 2025-Q3 | 99.63 | 4.05 | 101.2 | Buyer-sourced | 1 | 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-2026-041599 | CJC-1295 (no DAC) | QSC-2606-V7416 | VendorInvestigate | 2026-Q3 | 97.96 | 3.52 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-041601 | CJC-1295 (no DAC) | QSC-2606-V7416 | Kestrel | 2026-Q3 | 98.33 | 4.10 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041602 | CJC-1295 (no DAC) | QSC-2606-V7416 | VendorInvestigate | 2026-Q3 | 98.36 | 3.38 | 101.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041477 | Triptorelin | QSC-2607-C5749 | Nordanalyt | 2026-Q3 | 99.53 | 3.42 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041600 | CJC-1295 (no DAC) | QSC-2606-V7416 | Nordanalyt | 2026-Q3 | 97.74 | 4.91 | 100.9 | Buyer-sourced | 1 | FAIL |
| AX-2026-041603 | CJC-1295 (no DAC) | QSC-2606-V7416 | PeptideMeter | 2026-Q3 | 98.43 | 4.20 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041606 | CJC-1295 (no DAC) | QSC-2606-V7416 | Janoshik | 2026-Q3 | 98.03 | 3.58 | — | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041585 | Liraglutide | QSC-2605-W7381 | Medutest | 2026-Q3 | 99.59 | 5.09 | 92.8 | Laboratory-retained | 0 | PASS |