A retail vial at 99.62 % is worth more evidentially than a selected vial at a higher figure. That is the whole argument for recording provenance at all.
AX-2025-019066
MK-677 (Ibutamoren mesylate) · 1000 mg declared · GenScript Biotech Corporation · lot GSP-2501-R2783
FAILPURITY ONLY
- Report ID
- AX-2025-019066
- Compound
- MK-677 (Ibutamoren mesylate)
- Compound class
- Non-peptide adjuncts
- Supplier
- GSP — GenScript Biotech Corporation
- Batch / lot
- GSP-2501-R2783
- Declared label claim
- 1000mg
- Laboratory
- Medutest
- Assay date
- 17 Mar 2025
- Submitted
- 25 Mar 2025
- Quarter
- 2025-Q1
- Submitter
- m.chukwu
- 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, 25 min gradient, 214 nm | 99.62 | % area | ≥ 98.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.38 | % area | ≤ 1.5 | PASS |
| Largest single impurity | RP-HPLC — free base (des-mesylate, −96 Da) | 0.18 | % area | ≤ 1.00 | PASS |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 77.48 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 77.19 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 1182.09 | mg | 1000 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 912.455 | mg | 1000 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 91.2 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.02 | % | ≤ 10.0 | PASS |
| Counter-ion (mesylate) | anion-exchange ion chromatography | 15.74 | % | ≤ 12.0 | FAIL |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.76 | % | — | 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 | 4.18 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 11.75 | min | 11.73 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.93 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 69,201 | — | ≥ 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 | 11.75 | 4,841,841 | 99.62 | — |
| 2 | free base (des-mesylate, −96 Da) | 11.78 | 8,749 | 0.18 | -96.011 |
| 3 | spiroindane regioisomer | 12.12 | 5,346 | 0.11 | 0.000 |
| 4 | residual DMF (process solvent) | 4.92 | 3,402 | 0.07 | -551.000 |
| 5 | O-desmethyl metabolite analogue (−14 Da) | 11.32 | 972 | 0.02 | -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.
| Component | Determination | %w/w of cake |
|---|---|---|
| Water | Karl Fischer | 6.02 |
| Counter-ion (mesylate) | ion chromatography | 15.74 |
| Residual solvent + inorganic residue | estimated | 0.76 |
| Total peptide content | by difference | 77.48 |
| 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) | 100.0 | 99.62 | divergence +0.53 pp vs batch median |
| Total impurities (% area) | not stated | 0.38 | |
| Largest single impurity (% area) | not stated | 0.18 | |
| Water (%) | 4.6 | 6.02 | |
| Counter-ion (%) | 3.3 | 15.74 | |
| Peptide content (%w/w) | 91.5 | 77.48 | |
| Endotoxin (EU/mg) | 0.87 | 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 → third-party forwarder (33 d) → laboratory (courier, cold pack, 4 d) → assay.
- Assay date
- 17 Mar 2025
- Submitted to the index
- 25 Mar 2025
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- PURITY ONLY
Section 6
Annotations 4
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.
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.
The resolution figure sits in the system-suitability block with no PASS or FAIL beside it. That is deliberate: the index reports it and adjudicates nothing against it.
Two laboratories with different gradients will resolve a close pair differently and report two honest, different purities. Neither is wrong and the difference is not a disagreement about the material.
Section 7
Related records
Same batch — lot GSP-2501-R2783 n=10
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-019057 | GSP-2501-R2783 | Medutest | 2025-Q1 | 99.45 | 6.07 | 96.3 | Buyer-sourced | 0 | FAIL |
| AX-2025-019058 | GSP-2501-R2783 | Janoshik | 2025-Q1 | 99.62 | 6.26 | 105.6 | Laboratory-retained | 0 | FAIL |
| AX-2025-019059 | GSP-2501-R2783 | VendorInvestigate | 2025-Q1 | 98.90 | 5.43 | 103.0 | Buyer-sourced | 0 | FAIL |
| AX-2025-019060 | GSP-2501-R2783 | PeptideMeter | 2025-Q1 | 99.43 | 5.64 | 90.3 | Buyer-sourced | 0 | FAIL |
| AX-2025-019061 | GSP-2501-R2783 | Janoshik | 2025-Q1 | 99.49 | 5.70 | — | Buyer-sourced | 0 | FAIL |
| AX-2025-019062 | GSP-2501-R2783 | Medutest | 2025-Q1 | 99.85 | 5.91 | — | Buyer-sourced | 0 | FAIL |
| AX-2025-019063 | GSP-2501-R2783 | Medutest | 2025-Q1 | 99.93 | 4.98 | — | Supplier-supplied | 1 | FAIL |
| AX-2025-019064 | GSP-2501-R2783 | PeptideMeter | 2025-Q1 | 99.41 | 5.84 | — | Buyer-sourced | 0 | FAIL |
| AX-2025-019065 | GSP-2501-R2783 | Nordanalyt | 2025-Q1 | 99.26 | 6.13 | — | Laboratory-retained | 0 | 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-2026-041831 | Survodutide | GSP-2603-E3156 | Kestrel | 2026-Q3 | 99.91 | 5.50 | 93.2 | Buyer-sourced | 0 | PASS |
| AX-2026-041836 | Survodutide | GSP-2603-E3156 | Janoshik | 2026-Q3 | 98.65 | 5.34 | 90.3 | Buyer-sourced | 0 | PASS |
| AX-2026-041837 | Survodutide | GSP-2603-E3156 | Janoshik | 2026-Q3 | 98.33 | 5.37 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041833 | Survodutide | GSP-2603-E3156 | Janoshik | 2026-Q3 | 98.08 | 4.91 | 99.3 | Buyer-sourced | 0 | PASS |
| AX-2026-041832 | Survodutide | GSP-2603-E3156 | VendorInvestigate | 2026-Q3 | 98.01 | 5.14 | 99.5 | Buyer-sourced | 0 | PASS |
| AX-2026-041835 | Survodutide | GSP-2603-E3156 | Nordanalyt | 2026-Q3 | 98.34 | 5.74 | 89.0 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-041834 | Survodutide | GSP-2603-E3156 | VendorInvestigate | 2026-Q3 | 97.92 | 5.95 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041838 | Survodutide | GSP-2603-E3156 | PeptideMeter | 2026-Q3 | 98.30 | 5.01 | 102.4 | Buyer-sourced | 0 | PASS |