AssayIndex

SWB-2505-G5727

MK-677 (Ibutamoren mesylate) · 250 mg declared · Shanghai Wibson Biotechnology Co., Ltd. · manufactured 01 May 2025

SINGLE TEST
Lot code
SWB-2505-G5727
Supplier
SWB — Shanghai Wibson Biotechnology Co., Ltd.
Compound
MK-677 (Ibutamoren mesylate)
Compound class
Non-peptide adjuncts
Declared label claim
250mg
Manufacture date
01 May 2025
Index quarter
2025-Q3
Independent assays
1
Laboratories involved
VendorInvestigate
Provenance mix
Buyer-sourced ×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 1
Median purity 99.16% n=1
Spread (max − min) n<2 n=1
Standard deviation n<3 n=1
96.997.498.098.599.199.6100.2All 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 1

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-2025-019939SWB-2505-G5727VendorInvestigate2025-Q399.163.3088.7Buyer-sourced2FAIL
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
VendorInvestigate199.1699.1632min-0.1199.27

A single laboratory assayed this lot, so it contributes no paired comparison and the bias-adjusted column is a subtraction rather than a measurement.

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)99.9099.16divergence +0.74 pp vs batch median
Total impurities (% area)not stated0.84
Largest single impurity (% area)not stated0.60
Water (%)not stated3.30
Counter-ion (%)5.014.56
Peptide content (%w/w)90.981.94
Endotoxin (EU/mg)0.830.74
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)1 / 10.60
spiroindane regioisomer1 / 10.10
sulfonamide hydrolysis product (+18 Da)1 / 10.10
O-desmethyl metabolite analogue (−14 Da)1 / 10.02
residual DMF (process solvent)1 / 10.02
Section 7

What this rollup does not establish