AssayIndex

HJ-2501-G2609

MK-677 (Ibutamoren mesylate) · 500 mg declared · Hubei Jianxiang Bioscience Co., Ltd. · manufactured 24 Jan 2025

SINGLE TEST
Lot code
HJ-2501-G2609
Supplier
HJ — Hubei Jianxiang Bioscience Co., Ltd.
Compound
MK-677 (Ibutamoren mesylate)
Compound class
Non-peptide adjuncts
Declared label claim
500mg
Manufacture date
24 Jan 2025
Index quarter
2025-Q2
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 99.11% 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-2025-019699HJ-2501-G2609VendorInvestigate2025-Q299.115.22Buyer-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
VendorInvestigate199.1199.1132min-0.1199.22

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)99.9099.11divergence +0.79 pp vs batch median
Total impurities (% area)0.100.89
Largest single impurity (% area)0.070.41
Water (%)5.05.22
Counter-ion (%)not stated13.82
Peptide content (%w/w)90.2not determined
Endotoxin (EU/mg)0.18not 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
sulfonamide hydrolysis product (+18 Da)1 / 10.41
free base (des-mesylate, −96 Da)1 / 10.30
O-desmethyl metabolite analogue (−14 Da)1 / 10.08
residual DMF (process solvent)1 / 10.07
spiroindane regioisomer1 / 10.03
Section 7

What this rollup does not establish