Retail purchases test the retail channel. Manufacturer-tier material bought at kilogram scale is a different product with different documentation, and this index sees very little of it.
AX-2024-005356
MK-677 (Ibutamoren mesylate) · 250 mg declared · Sigma-Aldrich (Shanghai) Trading Co., Ltd. · lot SIG-2404-6898
FAILPURITY ONLY
- Report ID
- AX-2024-005356
- Compound
- MK-677 (Ibutamoren mesylate)
- Compound class
- Non-peptide adjuncts
- Supplier
- SIG — Sigma-Aldrich (Shanghai) Trading Co., Ltd.
- Batch / lot
- SIG-2404-6898
- Declared label claim
- 250mg
- Laboratory
- PeptideMeter
- Assay date
- 06 Sep 2024
- Submitted
- 13 Sep 2024
- Quarter
- 2024-Q3
- Submitter
- h.kravchenko
- 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 | 98.74 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.26 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — sulfonamide hydrolysis product (+18 Da) | 0.71 | % 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 | 3.36 | % | ≤ 10.0 | PASS |
| Counter-ion (mesylate) | anion-exchange ion chromatography | 14.08 | % | ≤ 12.0 | FAIL |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.87 | % | — | 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 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 | 5.67 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 12.94 | min | 13.01 ± 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 | 64,782 | — | ≥ 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 | 12.94 | 4,799,070 | 98.74 | — |
| 2 | sulfonamide hydrolysis product (+18 Da) | 12.14 | 34,508 | 0.71 | +18.011 |
| 3 | spiroindane regioisomer | 13.35 | 12,151 | 0.25 | 0.000 |
| 4 | residual DMF (process solvent) | 5.29 | 6,318 | 0.13 | -551.000 |
| 5 | free base (des-mesylate, −96 Da) | 12.98 | 4,374 | 0.09 | -96.011 |
| 6 | O-desmethyl metabolite analogue (−14 Da) | 12.45 | 3,888 | 0.08 | -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 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) | 98.43 | 98.74 | divergence -0.40 pp vs batch median |
| Total impurities (% area) | not stated | 1.26 | |
| Largest single impurity (% area) | not stated | 0.71 | |
| Water (%) | 3.1 | 3.36 | |
| Counter-ion (%) | not stated | 14.08 | |
| Peptide content (%w/w) | not stated | 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 (2–8 °C, 3 d) → laboratory (courier, ambient, 3 d) → assay.
- Assay date
- 06 Sep 2024
- Submitted to the index
- 13 Sep 2024
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-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.
I run trifluoroacetate on everything that arrives, and the distribution is wider than the certificates suggest. Where the number is measured it is usually reasonable; where it is absent it is unknowable.
No endotoxin figure on this record, which is true of roughly three quarters of the index. It is the one measurement that cannot be inferred from any other and the one most often omitted.
Section 7
Related records
Same batch — lot SIG-2404-6898 n=9
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-005354 | SIG-2404-6898 | PeptideMeter | 2024-Q3 | 98.86 | 3.81 | 99.1 | Buyer-sourced | 0 | FAIL |
| AX-2024-005355 | SIG-2404-6898 | Janoshik | 2024-Q3 | 98.82 | 3.54 | — | Buyer-sourced | 0 | FAIL |
| AX-2024-005357 | SIG-2404-6898 | Janoshik | 2024-Q3 | 99.09 | 3.36 | 91.8 | Laboratory-retained | 0 | FAIL |
| AX-2024-005358 | SIG-2404-6898 | Janoshik | 2024-Q3 | 98.93 | 3.02 | 104.7 | Buyer-sourced | 0 | FAIL |
| AX-2024-005359 | SIG-2404-6898 | Medutest | 2024-Q3 | 98.83 | 3.00 | — | Buyer-sourced | 0 | FAIL |
| AX-2024-005360 | SIG-2404-6898 | Janoshik | 2024-Q3 | 98.83 | 4.03 | 90.3 | Buyer-sourced | 0 | FAIL |
| AX-2024-005361 | SIG-2404-6898 | Janoshik | 2024-Q3 | 98.38 | 3.18 | 90.4 | Buyer-sourced | 0 | FAIL |
| AX-2024-005362 | SIG-2404-6898 | VendorInvestigate | 2024-Q3 | 99.00 | 3.87 | 97.2 | 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-2026-043535 | GHRP-2 | SIG-2603-6031 | Janoshik | 2026-Q3 | 99.12 | 1.26 | 105.7 | Buyer-sourced | 0 | PASS |
| AX-2026-043541 | GHRP-2 | SIG-2603-6031 | PeptideMeter | 2026-Q3 | 99.06 | 2.08 | 107.4 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043539 | GHRP-2 | SIG-2603-6031 | Janoshik | 2026-Q3 | 98.95 | 1.74 | 100.4 | Buyer-sourced | 1 | FAIL |
| AX-2026-043534 | GHRP-2 | SIG-2603-6031 | Medutest | 2026-Q3 | 99.11 | 2.15 | 89.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043542 | GHRP-2 | SIG-2603-6031 | VendorInvestigate | 2026-Q3 | 99.05 | 1.43 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-043543 | GHRP-2 | SIG-2603-6031 | Janoshik | 2026-Q3 | 99.38 | 1.70 | 98.6 | Buyer-sourced | 0 | PASS |
| AX-2026-043544 | GHRP-2 | SIG-2603-6031 | PeptideMeter | 2026-Q3 | 99.57 | 1.51 | 105.4 | Buyer-sourced | 0 | PASS |
| AX-2026-043538 | GHRP-2 | SIG-2603-6031 | Kestrel | 2026-Q3 | 98.93 | 1.72 | — | Buyer-sourced | 0 | FAIL |