AssayIndex

GLBI-2501-Y8359

MK-677 (Ibutamoren mesylate) · 500 mg declared · GL Biochem (Shanghai) Ltd. · manufactured 26 Jan 2025

CHARACTERISEDSHARED BULK
Lot code
GLBI-2501-Y8359
Supplier
GL Biochem — GL Biochem (Shanghai) Ltd.
Compound
MK-677 (Ibutamoren mesylate)
Compound class
Non-peptide adjuncts
Declared label claim
500mg
Manufacture date
26 Jan 2025
Index quarter
2025-Q2
Independent assays
13
Laboratories involved
Medutest, PeptideMeter, Janoshik, VendorInvestigate
Provenance mix
Buyer-sourced ×4 · Supplier-supplied ×9
Section 1

Reproducibility across independent tests

Every report below is an observation of the same physical material. What they disagree about is measurement; what they agree about is the lot. The size of the disagreement is compared against what the contributing laboratories' own repeatability figures predict.

Independent assays 13
Median purity 98.52% n=13
Spread (max − min) 1.23pp n=13
Standard deviation 0.343pp n=13
96.997.498.098.599.199.6100.2This lot (GLBI-2501-Y8359)This lot (GLBI-2501-Y8359): Q1 98.26, median 98.52, Q3 98.72, n=13n=13All MK-677 (Ibutamoren mesylate)All MK-677 (Ibutamoren mesylate): Q1 98.51, median 99.37, Q3 99.77, n=152n=152 Purity (% area)
Figure 1. This lot's independent purity results against the whole MK-677 (Ibutamoren mesylate) record set in the index. The vertical line is the index acceptance specification for the non-peptide adjuncts class, 98.5 % area. A narrow box on the top row against a wide box on the bottom row is the ideal reading: it means the disagreement between lots is much larger than the disagreement within this one.
Section 2

Member reports 13

Every report the index holds on this lot. Each is a page carrying its own chromatogram, mass spectrum, mass balance, provenance and caveats.

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020674GLBI-2501-Y8359Medutest2025-Q298.535.4099.0Supplier-supplied3FAIL
AX-2025-020675GLBI-2501-Y8359PeptideMeter2025-Q297.875.6499.9Supplier-supplied3FAIL
AX-2025-020676GLBI-2501-Y8359Janoshik2025-Q298.484.6290.6Supplier-supplied3FAIL
AX-2025-020677GLBI-2501-Y8359Janoshik2025-Q299.015.0592.8Supplier-supplied3FAIL
AX-2025-020678GLBI-2501-Y8359VendorInvestigate2025-Q298.265.1293.7Buyer-sourced4FAIL
AX-2025-020679GLBI-2501-Y8359Janoshik2025-Q298.524.88106.1Supplier-supplied3FAIL
AX-2025-020680GLBI-2501-Y8359Janoshik2025-Q298.725.10Supplier-supplied3FAIL
AX-2025-020681GLBI-2501-Y8359PeptideMeter2025-Q298.235.69Buyer-sourced3FAIL
AX-2025-020682GLBI-2501-Y8359PeptideMeter2025-Q298.805.3699.7Supplier-supplied3FAIL
AX-2025-020683GLBI-2501-Y8359VendorInvestigate2025-Q298.265.67102.2Buyer-sourced3FAIL
AX-2025-020684GLBI-2501-Y8359Medutest2025-Q299.105.4692.3Supplier-supplied3FAIL
AX-2025-020685GLBI-2501-Y8359PeptideMeter2025-Q298.545.17Supplier-supplied3FAIL
AX-2025-020686GLBI-2501-Y8359VendorInvestigate2025-Q298.244.66Buyer-sourced3FAIL
Section 3

By laboratory

Where more than one laboratory assayed this lot, the difference between them is a paired observation of their relative bias — the same material, the same time window, different instruments. Those pairs are what the index's bias estimates are built from.

LaboratoryReportsPurity results (% area)MedianGradientPublished bias (pp)Bias-adjusted
Medutest298.53, 99.1098.8125min+0.0898.73
PeptideMeter497.87, 98.23, 98.80, 98.5498.3928min-0.0598.44
Janoshik498.48, 99.01, 98.52, 98.7298.6230min+0.0098.62
VendorInvestigate398.26, 98.26, 98.2498.2632min-0.1198.37

This lot contributes 6 paired comparisons to the inter-lab analysis.

Section 4

The supplier's certificate for this lot

One number the supplier wrote, beside the median of the numbers other people measured on the same physical material. That comparison is only available because the index groups by lot.

FigureSupplier COAThis reportIndex note
Purity (% area)99.098.53divergence +0.48 pp vs batch median
Total impurities (% area)1.001.47
Largest single impurity (% area)not stated0.87
Water (%)3.55.40
Counter-ion (%)not stated15.96
Peptide content (%w/w)not stated78.02
Endotoxin (EU/mg)not statednot determined
Method stated on certificateYEScolumn, gradient and wavelength given
Section 5

Impurity fingerprint

The named impurities reported across this lot's assays, with how consistently each was seen. A fingerprint is what allows two lot numbers held by different companies to be identified as one bulk.

Named impurityReported inMedian % areaRange
free base (des-mesylate, −96 Da)13 / 130.530.24–1.04
sulfonamide hydrolysis product (+18 Da)13 / 130.450.23–1.30
spiroindane regioisomer13 / 130.100.06–0.13
O-desmethyl metabolite analogue (−14 Da)13 / 130.060.04–0.08
residual DMF (process solvent)13 / 130.070.04–0.11
Section 6

Shared-bulk links

Rule AX-R09. Where impurity fingerprints and latent composition match across companies, the index treats the material as one bulk and counts it once in aggregates.

LotSold byRoleReportsMedian purity
QYB-2503-W6005QYBlinked child298.91
WXT-2408-P5247WXTlinked child199.43
GLBI-2501-Y8359GL Biochemthis lot1398.52
Section 7

What this rollup does not establish