AssayIndex

GLBI-2501-Y7989

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

CHARACTERISEDSHARED BULK
Lot code
GLBI-2501-Y7989
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
8
Laboratories involved
PeptideMeter, Nordanalyt, Janoshik, Kestrel
Provenance mix
Buyer-sourced ×5 · Supplier-supplied ×3
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 8
Median purity 98.88% n=8
Spread (max − min) 0.68pp n=8
Standard deviation 0.226pp n=8
97.798.198.598.999.399.7100.1This lot (GLBI-2501-Y7989)This lot (GLBI-2501-Y7989): Q1 98.72, median 98.88, Q3 99.00, n=8n=8All MK-677 (Ibutamoren mesylate)All MK-677 (Ibutamoren mesylate): Q1 99.11, median 99.49, Q3 99.80, n=143outlier 97.90outlier 97.95n=143 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 8

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-2025-020618GLBI-2501-Y7989PeptideMeter2025-Q298.735.01Buyer-sourced1FAIL
AX-2025-020619GLBI-2501-Y7989Nordanalyt2025-Q298.935.11Buyer-sourced1FAIL
AX-2025-020620GLBI-2501-Y7989PeptideMeter2025-Q298.824.94Buyer-sourced1FAIL
AX-2025-020621GLBI-2501-Y7989Janoshik2025-Q299.115.07106.9Supplier-supplied1FAIL
AX-2025-020622GLBI-2501-Y7989PeptideMeter2025-Q298.525.49Supplier-supplied1FAIL
AX-2025-020623GLBI-2501-Y7989Janoshik2025-Q298.974.56104.5Supplier-supplied1FAIL
AX-2025-020624GLBI-2501-Y7989Janoshik2025-Q298.694.68Buyer-sourced1FAIL
AX-2025-020625GLBI-2501-Y7989Kestrel2025-Q299.204.8893.2Buyer-sourced1FAIL
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
PeptideMeter398.73, 98.82, 98.5298.7328min-0.0598.78
Nordanalyt198.9398.9335min+0.0298.91
Janoshik399.11, 98.97, 98.6998.9730min+0.0098.97
Kestrel199.2099.2015min+0.2498.96

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)99.0398.73divergence +0.15 pp vs batch median
Total impurities (% area)0.971.27
Largest single impurity (% area)0.410.75
Water (%)3.95.01
Counter-ion (%)not stated13.87
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)0.450.41
Method stated on certificateNOno method section — the result cannot be reconciled against any other
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)8 / 80.480.19–0.87
sulfonamide hydrolysis product (+18 Da)8 / 80.430.30–0.66
spiroindane regioisomer8 / 80.070.05–0.11
O-desmethyl metabolite analogue (−14 Da)8 / 80.040.03–0.06
residual DMF (process solvent)8 / 80.050.04–0.06
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
CPC-2503-G2382CPClinked child798.75
BCH-2511-G5204BCHlinked child298.68
GLBI-2501-Y7989GL Biochemthis lot898.88
Section 7

What this rollup does not establish