AssayIndex

TFS-{CAT}-1096

MK-677 (Ibutamoren mesylate) · 250 mg declared · Thermo Fisher Scientific (China) Co., Ltd. · manufactured 09 May 2026

CHARACTERISED
Lot code
TFS-{CAT}-1096
Supplier
TFS — Thermo Fisher Scientific (China) Co., Ltd.
Compound
MK-677 (Ibutamoren mesylate)
Compound class
Non-peptide adjuncts
Declared label claim
250mg
Manufacture date
09 May 2026
Index quarter
2026-Q2
Independent assays
3
Laboratories involved
Janoshik, PeptideMeter
Provenance mix
Buyer-sourced ×2 · Laboratory-retained ×1
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 3
Median purity 99.14% n=3
Spread (max − min) 0.41pp n=3
Standard deviation 0.219pp n=3
97.798.198.598.999.399.7100.1This lot (TFS-{CAT}-1096)This lot (TFS-{CAT}-1096): Q1 99.10, median 99.14, Q3 99.31, n=3n=3All 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 3

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-2026-041732TFS-{CAT}-1096Janoshik2026-Q299.483.16106.4Buyer-sourced0FAIL
AX-2026-041733TFS-{CAT}-1096PeptideMeter2026-Q299.073.9395.1Laboratory-retained0FAIL
AX-2026-041734TFS-{CAT}-1096PeptideMeter2026-Q299.143.6491.2Buyer-sourced0FAIL
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
Janoshik199.4899.4830min+0.0099.48
PeptideMeter299.07, 99.1499.1028min-0.0599.15

This lot contributes 1 paired comparison 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)99.3199.48divergence +0.17 pp vs batch median
Total impurities (% area)0.690.52
Largest single impurity (% area)0.250.23
Water (%)3.03.16
Counter-ion (%)7.415.84
Peptide content (%w/w)89.080.76
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
O-desmethyl metabolite analogue (−14 Da)3 / 30.230.11–0.60
spiroindane regioisomer3 / 30.200.11–0.63
sulfonamide hydrolysis product (+18 Da)3 / 30.050.03–0.05
free base (des-mesylate, −96 Da)3 / 30.070.04–0.13
residual DMF (process solvent)2 / 30.030.03–0.03
Section 7

What this rollup does not establish