AssayIndex

AX-2025-018651

MK-677 (Ibutamoren mesylate) · 1000 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2507-F5673

FAILVERIFIED
Report ID
AX-2025-018651
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
Janoshik Analytical
Assay date
25 Sep 2025
Submitted
07 Oct 2025
Quarter
2025-Q3
Submitter
d.batista
Sample provenance
Laboratory-retained
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.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 30 min gradient, 214 nm99.74% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.26% area≤ 1.5PASS
Largest single impurityRP-HPLC — sulfonamide hydrolysis product (+18 Da)0.16% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula624.2181Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)624.2198Da—NOT TESTED
Mass accuracyobserved vs theoretical+2.7ppm± 10PASS
Total peptide contentby difference from the gravimetric mass balance79.58%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity79.37%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen1253.65mg1000 mg declaredNOT TESTED
Recovered target peptidegross fill × target content995.022mg1000 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim99.5%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.21%≤ 10.0PASS
Counter-ion (mesylate)anion-exchange ion chromatography15.93%≤ 12.0FAIL
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.28%—NOT TESTED
Endotoxinnot ordered on this submissionnot determined—≤ 5.0NOT TESTED
Sterilitynot ordered on this submissionnot determined—no growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite lyophilised cake, intact—white to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear after 90 s gentle swirling, no particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.80—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient13.64min13.86 ± 0.30 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.05—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²67,360—≥ 20,000PASS
Resolution to nearest impurityvs free base (des-mesylate, −96 Da)0.19—no index criterionREPORTED
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.

02144428864338577 MK-677 (Ibutamoren mesylate)13.64 min · 99.74 % 12.78 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 30 min gradient, 214 nm. Drawn from the peak-integration table below: peak positions are the reported retention times, peak areas are the reported area percentages, peak widths follow the reported plate count of 67,360, and skew follows the reported asymmetry factor of 1.05. Baseline noise is seeded from the report ID and is illustrative. The lower panel is the same trace at a stated vertical expansion with the slow gradient drift subtracted, because at full scale a 0.16 % impurity against a 99.74 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1MK-677 (Ibutamoren mesylate) — main peak13.644,847,67399.74—
2sulfonamide hydrolysis product (+18 Da)12.787,7760.16+18.011
3free base (des-mesylate, −96 Da)13.682,9160.06-96.011
4O-desmethyl metabolite analogue (−14 Da)13.129720.02-14.016
5spiroindane regioisomer14.089720.020.000
Closure check — purity + Σ impurities 100.00CLOSES

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.

0255075100250325400475550625700 [M+1H]1+625.23[M+2H]2+313.12 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 624.2198 Da. Sodium (+21.982/z) and potassium (+37.956/z) adducts are shown where the parent charge state exceeds 25 % relative abundance; they are adducts of the same molecule and are not impurities.
ChargeTheoretical m/zObserved m/zΔ m/zRel. abundance (%)
2+313.1163313.11720.000958.0
1+625.2254625.22710.0017100.0
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.

ComponentDetermination%w/w of cake
WaterKarl Fischer4.21
Counter-ion (mesylate)ion chromatography15.93
Residual solvent + inorganic residueestimated0.28
Total peptide contentby difference79.58
Total100.00 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.

FigureSupplier COAThis reportIndex note
Purity (% area)99.9099.74divergence +0.16 pp vs batch median
Total impurities (% area)0.100.26
Largest single impurity (% area)0.060.16
Water (%)4.24.21
Counter-ion (%)3.315.93
Peptide content (%w/w)97.979.58
Endotoxin (EU/mg)not statednot determined
Method stated on certificateYES—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
Laboratory-retained
Evidentiary weight
Provenance documented, selection uncontrolled.
Chain of custody
Laboratory retained sample (−20 °C, 21 d since original receipt) → re-assay.
Assay date
25 Sep 2025
Submitted to the index
07 Oct 2025
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
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.

sig_figs
Two decimal places on 99.74 % implies repeatability better than 0.01 pp, which no laboratory here claims. The number is sound; the printed precision is more than the method carries.
Index data team

Two decimal places are retained because the source reports carry them and truncating would discard information where a laboratory genuinely reports it. The uncertainty budget on /methods/uncertainty-budget/ is the right thing to read alongside any purity figure on this site.

diode_array
Photodiode-array spectral homogeneity across the main peak would convert 99.74 % from a good number into a checked one. It is a free measurement on any instrument that already has the detector.
ms_confirm
Purity at 99.74 % with identity confirmed on the same submission is the combination worth having. Either alone leaves a question the other answers.
quarter_over_quarter
Single records do not establish trends. Where this supplier's quarterly medians are stable across four quarters, a result like this reads as the process rather than the draw — and the timeline page is where to check that.
Section 7

Related records

Same batch — lot QSC-2507-F5673 n=11

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-018646QSC-2507-F5673Kestrel2025-Q399.654.78—Buyer-sourced1FAIL
AX-2025-018647QSC-2507-F5673PeptideMeter2025-Q399.794.29—Buyer-sourced1FAIL
AX-2025-018648QSC-2507-F5673Janoshik2025-Q399.724.26—Buyer-sourced1FAIL
AX-2025-018649QSC-2507-F5673Nordanalyt2025-Q399.794.54107.3Laboratory-retained1FAIL
AX-2025-018650QSC-2507-F5673Janoshik2025-Q399.614.34—Buyer-sourced1FAIL
AX-2025-018652QSC-2507-F5673Janoshik2025-Q399.524.27—Buyer-sourced1FAIL
AX-2025-018653QSC-2507-F5673Nordanalyt2025-Q399.874.4694.9Buyer-sourced1FAIL
AX-2025-018654QSC-2507-F5673PeptideMeter2025-Q399.794.78105.4Buyer-sourced1FAIL
AX-2025-018655QSC-2507-F5673Janoshik2025-Q399.784.3794.8Buyer-sourced1FAIL
AX-2025-018656QSC-2507-F5673Janoshik2025-Q399.634.05101.2Buyer-sourced1FAIL

Cross-sections

Other recent MK-677 (Ibutamoren mesylate) records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041633FGPFGP-2604-K8509PeptideMeter2026-Q299.814.9196.2Buyer-sourced0FAIL
AX-2026-041733TFSTFS-{CAT}-1096PeptideMeter2026-Q299.073.9395.1Laboratory-retained0FAIL
AX-2026-043468BCHBCH-2511-G5204Medutest2026-Q298.854.3096.5Buyer-sourced1FAIL
AX-2026-042647SWBSWB-2605-B7365Nordanalyt2026-Q299.282.8693.1Buyer-sourced0FAIL
AX-2026-041634FGPFGP-2604-K8509PeptideMeter2026-Q299.865.17—Buyer-sourced0FAIL
AX-2026-043469BCHBCH-2511-G5204Medutest2026-Q298.514.86—Buyer-sourced1FAIL
AX-2026-042648SWBSWB-2605-B7365Janoshik2026-Q299.932.6096.9Supplier-supplied0FAIL
AX-2026-041732TFSTFS-{CAT}-1096Janoshik2026-Q299.483.16106.4Buyer-sourced0FAIL
Other recent QSC records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041599CJC-1295 (no DAC)QSC-2606-V7416VendorInvestigate2026-Q397.963.52—Buyer-sourced1FAIL
AX-2026-041601CJC-1295 (no DAC)QSC-2606-V7416Kestrel2026-Q398.334.10—Buyer-sourced1MARGINAL
AX-2026-041602CJC-1295 (no DAC)QSC-2606-V7416VendorInvestigate2026-Q398.363.38101.8Buyer-sourced1MARGINAL
AX-2026-041477TriptorelinQSC-2607-C5749Nordanalyt2026-Q399.533.42—Buyer-sourced0PASS
AX-2026-041600CJC-1295 (no DAC)QSC-2606-V7416Nordanalyt2026-Q397.744.91100.9Buyer-sourced1FAIL
AX-2026-041603CJC-1295 (no DAC)QSC-2606-V7416PeptideMeter2026-Q398.434.20—Buyer-sourced1MARGINAL
AX-2026-041606CJC-1295 (no DAC)QSC-2606-V7416Janoshik2026-Q398.033.58—Buyer-sourced1MARGINAL
AX-2026-041585LiraglutideQSC-2605-W7381Medutest2026-Q399.595.0992.8Laboratory-retained0PASS