AssayIndex

AX-2025-020975

MK-677 (Ibutamoren mesylate) · 500 mg declared · Chinese Peptide Company Co., Ltd. · lot CPC-2503-G3418

FAILVERIFIED
Report ID
AX-2025-020975
Compound
MK-677 (Ibutamoren mesylate)
Compound class
Non-peptide adjuncts
Supplier
CPC — Chinese Peptide Company Co., Ltd.
Batch / lot
CPC-2503-G3418
Declared label claim
500mg
Laboratory
PeptideMeter
Assay date
10 Jun 2025
Submitted
16 Jun 2025
Quarter
2025-Q2
Submitter
lyo_cycle
Sample provenance
Supplier-supplied
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, 28 min gradient, 214 nm98.80% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.20% area≤ 1.5PASS
Largest single impurityRP-HPLC — sulfonamide hydrolysis product (+18 Da)0.47% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula624.2181Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)624.2180Da—NOT TESTED
Mass accuracyobserved vs theoretical-0.1ppm± 10PASS
Total peptide contentby difference from the gravimetric mass balance80.57%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity79.60%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen672.22mg500 mg declaredNOT TESTED
Recovered target peptidegross fill × target content535.087mg500 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim107.0%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.39%≤ 10.0PASS
Counter-ion (mesylate)anion-exchange ion chromatography13.55%≤ 12.0FAIL
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.49%—NOT TESTED
Endotoxinkinetic chromogenic LAL0.25EU/mg≤ 5.0PASS
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 d—no growthPASS
Appearancevisual, diffuse light, black and white backgroundOff-white 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 calibration4.64—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient13.05min13.01 ± 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)²71,815—≥ 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.

02293458768809173 MK-677 (Ibutamoren mesylate)13.05 min · 98.80 % 12.255.40 same trace · ×100 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 051015202530 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 28 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 71,815, 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 0.47 % impurity against a 98.80 % 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 peak13.054,801,98698.80—
2sulfonamide hydrolysis product (+18 Da)12.2522,8430.47+18.011
3spiroindane regioisomer13.4616,5250.340.000
4residual DMF (process solvent)5.408,2630.17-551.000
5free base (des-mesylate, −96 Da)13.095,8320.12-96.011
6O-desmethyl metabolite analogue (−14 Da)12.564,8600.10-14.016
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 624.2180 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+313.1163313.1163-0.000051.9
1+625.2254625.2253-0.0001100.0
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 Fischer5.39
Counter-ion (mesylate)ion chromatography13.55
Residual solvent + inorganic residueestimated0.49
Total peptide contentby difference80.57
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)98.7098.80divergence +0.54 pp vs batch median
Total impurities (% area)1.301.20
Largest single impurity (% area)not stated0.47
Water (%)not stated5.39
Counter-ion (%)not stated13.55
Peptide content (%w/w)not stated80.57
Endotoxin (EU/mg)0.310.25
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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 8 d) → assay. Submitter did not handle the vial.
Assay date
10 Jun 2025
Submitted to the index
16 Jun 2025
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 min gradient · high-resolution MS
Verification status
VERIFIED
Section 6

Annotations

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot CPC-2503-G3418 n=5

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020974CPC-2503-G3418VendorInvestigate2025-Q298.695.03101.1Buyer-sourced1FAIL
AX-2025-020976CPC-2503-G3418Janoshik2025-Q298.165.5791.4Supplier-supplied1FAIL
AX-2025-020977CPC-2503-G3418VendorInvestigate2025-Q297.964.93105.1Buyer-sourced1FAIL
AX-2025-020978CPC-2503-G3418VendorInvestigate2025-Q297.705.2095.9Buyer-sourced1FAIL

Cross-sections

Other recent MK-677 (Ibutamoren mesylate) records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043524BCHBCH-2511-G7276Janoshik2026-Q298.364.68—Supplier-supplied1FAIL
AX-2026-041764FGPFGP-2604-K1470Janoshik2026-Q299.935.34—Supplier-supplied1FAIL
AX-2026-043527BCHBCH-2511-G7276Janoshik2026-Q298.354.3695.5Supplier-supplied1FAIL
AX-2026-042409SWBSWB-2605-B4738Medutest2026-Q299.322.9994.9Laboratory-retained1FAIL
AX-2026-043526BCHBCH-2511-G7276Medutest2026-Q297.604.50—Buyer-sourced1FAIL
AX-2026-042410SWBSWB-2605-B4738Janoshik2026-Q299.612.81—Supplier-supplied1FAIL
AX-2026-041765FGPFGP-2604-K1470Janoshik2026-Q299.935.08—Supplier-supplied0FAIL
AX-2026-043525BCHBCH-2511-G7276Medutest2026-Q298.374.32—Buyer-sourced1FAIL
Other recent CPC records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043368N-Acetyl Semax AmideCPC-2602-D2941Medutest2026-Q398.796.05102.1Supplier-supplied0PASS
AX-2026-043335LiraglutideCPC-2602-G1978Janoshik2026-Q397.294.91—Laboratory-retained1FAIL
AX-2026-043283L-CarnosineCPC-2603-G1651Medutest2026-Q398.1010.1291.8Supplier-supplied1FAIL
AX-2026-043365BPC-157CPC-2602-W2646Medutest2026-Q398.562.80—Supplier-supplied1MARGINAL
AX-2026-043332LiraglutideCPC-2602-G1978Janoshik2026-Q397.164.8891.3Supplier-supplied1FAIL
AX-2026-043289L-CarnosineCPC-2603-G1651Janoshik2026-Q398.0110.52—Buyer-sourced1FAIL
AX-2026-043287L-CarnosineCPC-2603-G1651Janoshik2026-Q398.359.8993.2Supplier-supplied2FAIL
AX-2026-043367N-Acetyl Semax AmideCPC-2602-D2941Nordanalyt2026-Q399.396.1692.4Supplier-supplied0PASS