AX-2025-020897 · MK-677 (Ibutamoren mesylate) · WXT lot WXT-2502-F2050

Section 1

Results

Measured against the index acceptance specification for the non-peptide adjuncts class. A specification is a decision the index made; a result is a measurement. See where each threshold came from.

Parameter	Method	Result	Unit	Index spec
Purity	RP-HPLC, 30 min gradient, 214 nm	99.20	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.80	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — residual DMF (process solvent)	0.57	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	79.22	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	78.59	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	1167.08	mg	1000 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	917.208	mg	1000 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	91.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.39	%	≤ 10.0	PASS
Counter-ion (mesylate)	anion-exchange ion chromatography	15.62	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.77	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
Appearance	visual, diffuse light, black and white background	Off-white lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Visible particulates, did not clear	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.15	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	14.69	min	13.86 ± 0.30 (normalised)	FAIL
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.08	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	62,357	—	≥ 20,000	PASS
Resolution to nearest impurity	vs free base (des-mesylate, −96 Da)	0.17	—	no index criterion	REPORTED

Section 2

Chromatogram and peak integration

The figure is drawn from the table. It is not an independent illustration — if a number in the table changed, the trace would change with it.

Figure 1. RP-HPLC trace, 30 min gradient, 214 nm. Drawn from the peak-integration table below: peak positions are the reported retention times, peak areas are the reported area percentages, peak widths follow the reported plate count of 62,357, and skew follows the reported asymmetry factor of 1.08. Baseline noise is seeded from the report ID and is illustrative. The lower panel is the same trace at a stated vertical expansion with the slow gradient drift subtracted, because at full scale a 0.57 % impurity against a 99.20 % main peak is a line two pixels tall; the main peak runs off-scale there by design.

#	Peak	RT	Area (µV·s)	% area	Δ mass (Da)
1	MK-677 (Ibutamoren mesylate) — main peak	14.69	4,821,428	99.20	—
2	residual DMF (process solvent)	6.49	27,704	0.57	-551.000
3	sulfonamide hydrolysis product (+18 Da)	13.83	5,346	0.11	+18.011
4	O-desmethyl metabolite analogue (−14 Da)	14.17	3,402	0.07	-14.016
5	free base (des-mesylate, −96 Da)	14.73	1,458	0.03	-96.011
6	spiroindane regioisomer	15.13	972	0.02	0.000
Closure check — purity + Σ impurities				100.00	CLOSES

Reporting threshold 0.05 % area. Peaks below it are not reported and are therefore excluded from the total, which overstates purity by their sum — see peak integration.

Section 4

Gravimetric mass balance

Water, counter-ion, residual and total peptide content are exhaustive and mutually exclusive categories. They must account for 100 % of the cake mass. The index closes this to within 0.02 pp and the build asserts it.

Component	Determination	%w/w of cake
Water	Karl Fischer	4.39
Counter-ion (mesylate)	ion chromatography	15.62
Residual solvent + inorganic residue	estimated	0.77
Total peptide content	by difference	79.22
Total		100.00 CLOSES

Supplier certificate, as declared

The supplier's own figures for this lot, beside the independent measurement. Divergence is assessed against the batch median, not against this single report — see rule AX-R05.

Figure	Supplier COA	This report	Index note
Purity (% area)	99.82	99.20	divergence +0.21 pp vs batch median
Total impurities (% area)	0.18	0.80
Largest single impurity (% area)	0.11	0.57
Water (%)	2.4	4.39
Counter-ion (%)	not stated	15.62
Peptide content (%w/w)	not stated	79.22
Endotoxin (EU/mg)	not stated	not determined
Method stated on certificate	YES	—	column, gradient and wavelength given

Section 5

Provenance and caveats

Where a sample came from changes the weight of the evidence. The index treats it as a first-class field.

Sample provenance: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Retail purchase → submitter (ambient, 6 d) → laboratory (courier, cold pack, 2 d) → assay.
Assay date: 24 Mar 2025
Submitted to the index: 06 Apr 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: PURITY ONLY

What this report does not establish

That the compound is the compound named. No identity confirmation was ordered on this submission. A purity figure describes chromatographic homogeneity of whatever eluted; it does not name it.
That the material is free of bacterial endotoxin. Endotoxin was not measured. No chromatographic result bears on it.
That the material is sterile. Sterility was not tested.
That any other vial in the same lot has the same composition. One vial was tested. Within-lot vial-to-vial variation in this index has a median of 0.28 pp and a 90th percentile of 0.74 pp.
That any other lot from the same supplier has the same composition. Batch-to-batch variation is larger than within-batch variation for every supplier here.
That the material is suitable for administration to a human or an animal. These are research compounds. No result on this site is a safety assessment and the index takes no position on use.
That the material was manufactured by the supplier that sold it. Contract synthesis is normal in this market and twenty-nine batches in the index fingerprint to a bulk from a different company than the one named on the label.

Section 6

Annotations 3

Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.

buyer_sourced06 Apr 2025

Buyer-sourced through an ordinary retail order, so the supplier had no opportunity to select the vial. This is the provenance class the index weights and it is roughly 87 % of the dataset.

price_per_mg06 Apr 2025

A retail vial at 99.20 % is worth more evidentially than a selected vial at a higher figure. That is the whole argument for recording provenance at all.

lot_traceability06 Apr 2025

Lot WXT-2502-F2050 on the vial matches the certificate that came with it. That is the check every buyer can do in ten seconds and most do not.

Section 7

Related records

Same batch — lot WXT-2502-F2050 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020898	WXT-2502-F2050	PeptideMeter	2025-Q1	99.64	4.40	—	Buyer-sourced	0	FAIL
AX-2025-020899	WXT-2502-F2050	VendorInvestigate	2025-Q1	99.59	4.78	—	Buyer-sourced	1	FAIL
AX-2025-020900	WXT-2502-F2050	PeptideMeter	2025-Q1	99.48	4.33	90.2	Buyer-sourced	0	FAIL
AX-2025-020901	WXT-2502-F2050	Janoshik	2025-Q1	99.45	4.41	—	Buyer-sourced	0	FAIL
AX-2025-020902	WXT-2502-F2050	Medutest	2025-Q1	99.72	4.14	106.8	Buyer-sourced	0	FAIL
AX-2025-020903	WXT-2502-F2050	Janoshik	2025-Q1	99.62	4.12	100.8	Buyer-sourced	0	FAIL
AX-2025-020904	WXT-2502-F2050	Janoshik	2025-Q1	99.70	4.69	101.0	Buyer-sourced	0	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

All MK-677 (Ibutamoren mesylate) records n=143
All WXT records n=301
All Janoshik records n=2989
All 2025-Q1 records n=672
MK-677 (Ibutamoren mesylate) by supplier
MK-677 (Ibutamoren mesylate) impurity profile

Other recent MK-677 (Ibutamoren mesylate) records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041633	FGP	FGP-2604-K8509	PeptideMeter	2026-Q2	99.81	4.91	96.2	Buyer-sourced	0	FAIL
AX-2026-041733	TFS	TFS-{CAT}-1096	PeptideMeter	2026-Q2	99.07	3.93	95.1	Laboratory-retained	0	FAIL
AX-2026-043468	BCH	BCH-2511-G5204	Medutest	2026-Q2	98.85	4.30	96.5	Buyer-sourced	1	FAIL
AX-2026-042647	SWB	SWB-2605-B7365	Nordanalyt	2026-Q2	99.28	2.86	93.1	Buyer-sourced	0	FAIL
AX-2026-041634	FGP	FGP-2604-K8509	PeptideMeter	2026-Q2	99.86	5.17	—	Buyer-sourced	0	FAIL
AX-2026-043469	BCH	BCH-2511-G5204	Medutest	2026-Q2	98.51	4.86	—	Buyer-sourced	1	FAIL
AX-2026-042648	SWB	SWB-2605-B7365	Janoshik	2026-Q2	99.93	2.60	96.9	Supplier-supplied	0	FAIL
AX-2026-041732	TFS	TFS-{CAT}-1096	Janoshik	2026-Q2	99.48	3.16	106.4	Buyer-sourced	0	FAIL

Other recent WXT records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043376	Semaglutide	WXT-2604-C3248	Janoshik	2026-Q3	97.08	4.22	—	Buyer-sourced	1	MARGINAL
AX-2026-043429	L-Glutathione (reduced)	WXT-2605-B3833	Nordanalyt	2026-Q3	98.48	6.58	96.9	Supplier-supplied	1	FAIL
AX-2026-043347	Leuprolide	WXT-2604-K2596	PeptideMeter	2026-Q3	99.16	5.99	93.6	Buyer-sourced	0	PASS
AX-2026-043353	Leuprolide	WXT-2604-K2596	Janoshik	2026-Q3	99.19	4.90	95.3	Laboratory-retained	0	PASS
AX-2026-043345	Leuprolide	WXT-2604-K2596	Janoshik	2026-Q3	98.93	5.28	—	Buyer-sourced	0	PASS
AX-2026-043424	L-Glutathione (reduced)	WXT-2605-B3833	PeptideMeter	2026-Q3	98.37	6.86	—	Buyer-sourced	0	FAIL
AX-2026-043374	Semaglutide	WXT-2604-C3248	Janoshik	2026-Q3	97.00	3.56	—	Buyer-sourced	1	MARGINAL
AX-2026-043377	Semaglutide	WXT-2604-C3248	PeptideMeter	2026-Q3	97.20	4.08	—	Buyer-sourced	1	MARGINAL