AssayIndex

AX-2025-019788

MK-677 (Ibutamoren mesylate) · 250 mg declared · Hunan Aslsen Technology Co., Ltd. · lot HOMO-2506-L4686

FAILIDENTITY CONSISTENT
Report ID
AX-2025-019788
Compound
MK-677 (Ibutamoren mesylate)
Compound class
Non-peptide adjuncts
Supplier
Homopeptide — Hunan Aslsen Technology Co., Ltd.
Batch / lot
HOMO-2506-L4686
Declared label claim
250mg
Laboratory
Janoshik Analytical
Assay date
18 Dec 2025
Submitted
30 Dec 2025
Quarter
2025-Q4
Submitter
cake_collapse
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.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 30 min gradient, 214 nm99.72% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.28% area≤ 1.5PASS
Largest single impurityRP-HPLC — spiroindane regioisomer0.16% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula624.2181Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)624.2187Da—NOT TESTED
Mass accuracyobserved vs theoretical+1.0ppm± 10PASS
Peptide contentnot ordered on this submissionnot determined—required to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate1.45%≤ 10.0PASS
Counter-ion (mesylate)anion-exchange ion chromatography15.71%≤ 12.0FAIL
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.47%—NOT TESTED
Endotoxinnot ordered on this submissionnot determined—≤ 5.0NOT TESTED
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 d—no growthPASS
Appearancevisual, diffuse light, black and white backgroundWhite lyophilised cake, intact—white to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.63—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient13.97min13.86 ± 0.30 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.12—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²67,246—≥ 20,000PASS
Resolution to nearest impurityvs free base (des-mesylate, −96 Da)0.18—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.

02022404560678089 MK-677 (Ibutamoren mesylate)13.97 min · 99.72 % 14.41 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 67,246, and skew follows the reported asymmetry factor of 1.12. 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 99.72 % 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 peak13.974,846,70199.72—
2spiroindane regioisomer14.417,7760.160.000
3free base (des-mesylate, −96 Da)14.012,9160.06-96.011
4O-desmethyl metabolite analogue (−14 Da)13.451,9440.04-14.016
5sulfonamide hydrolysis product (+18 Da)13.119720.02+18.011
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 624.2187 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+313.1163313.11660.000357.0
1+625.2254625.22600.0006100.0
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.

FigureSupplier COAThis reportIndex note
Purity (% area)99.9099.72divergence -0.03 pp vs batch median
Total impurities (% area)0.100.28
Largest single impurity (% area)0.040.16
Water (%)0.81.45
Counter-ion (%)not stated15.71
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)not statednot determined
Method stated on certificateNO—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
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Retail purchase → submitter (ambient, 31 d) → laboratory (hand-carried, 4 d) → assay.
Assay date
18 Dec 2025
Submitted to the index
30 Dec 2025
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
IDENTITY CONSISTENT
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.

prep_hplc_cut
0.28 % total impurities on MK-677 (Ibutamoren mesylate) means the preparative fraction was cut narrow. That trades yield for purity, and the trade was made in the buyer's favour on this lot.
plate_count
Plate count on this run supports the separation claimed. A high purity figure from an inefficient column is a merged peak reported as a clean one; that is not what happened here.
storage_stated
The index cannot verify that the vial assayed is representative of the lot it came from, and says so on every record. Provenance narrows that gap; it does not close it.
Section 7

Related records

Same batch — lot HOMO-2506-L4686 n=13

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-019787HOMO-2506-L4686Janoshik2025-Q499.931.8191.7Buyer-sourced0FAIL
AX-2025-019789HOMO-2506-L4686Medutest2025-Q499.931.59—Buyer-sourced0FAIL
AX-2025-019790HOMO-2506-L4686Medutest2025-Q499.931.09—Buyer-sourced1FAIL
AX-2025-019791HOMO-2506-L4686VendorInvestigate2025-Q499.701.37102.4Buyer-sourced0FAIL
AX-2025-019792HOMO-2506-L4686Janoshik2025-Q499.891.4095.5Buyer-sourced0FAIL
AX-2025-019793HOMO-2506-L4686Janoshik2025-Q499.511.23—Buyer-sourced0FAIL
AX-2025-019794HOMO-2506-L4686PeptideMeter2025-Q499.931.59—Buyer-sourced0FAIL
AX-2025-019795HOMO-2506-L4686PeptideMeter2025-Q499.931.31103.3Buyer-sourced0FAIL
AX-2025-019796HOMO-2506-L4686Janoshik2025-Q499.931.00—Buyer-sourced1FAIL
AX-2025-019797HOMO-2506-L4686Janoshik2025-Q499.801.22105.9Buyer-sourced0FAIL
AX-2025-019798HOMO-2506-L4686Medutest2025-Q499.931.34—Buyer-sourced1FAIL
AX-2025-019799HOMO-2506-L4686Kestrel2025-Q499.931.74—Buyer-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 Homopeptide records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042437RetatrutideHOMO-2605-V4718Nordanalyt2026-Q398.683.67102.8Buyer-sourced0PASS
AX-2026-042424SemaglutideHOMO-2604-X3806PeptideMeter2026-Q398.854.8792.0Buyer-sourced0PASS
AX-2026-042503IGF-1 LR3HOMO-2607-P5131Janoshik2026-Q399.365.99—Buyer-sourced0PASS
AX-2026-042492SS-31 (Elamipretide)HOMO-2604-D5484Medutest2026-Q399.932.40—Buyer-sourced0PASS
AX-2026-042491SS-31 (Elamipretide)HOMO-2604-D5484Kestrel2026-Q399.933.24—Supplier-supplied0PASS
AX-2026-042473LL-37HOMO-2602-G5165Janoshik2026-Q399.015.00—Buyer-sourced0PASS
AX-2026-042441RetatrutideHOMO-2605-V4718Medutest2026-Q398.934.22—Buyer-sourced0PASS
AX-2026-042474LL-37HOMO-2602-G5165Janoshik2026-Q399.185.44—Buyer-sourced0PASS