AX-2026-041732

MK-677 (Ibutamoren mesylate) · 250 mg declared · Thermo Fisher Scientific (China) Co., Ltd. · lot TFS-{CAT}-1096

FAILVERIFIED

Report ID: AX-2026-041732
Compound: MK-677 (Ibutamoren mesylate)
Compound class: Non-peptide adjuncts
Supplier: TFS — Thermo Fisher Scientific (China) Co., Ltd.
Batch / lot: TFS-{CAT}-1096
Declared label claim: 250mg
Laboratory: Janoshik Analytical
Assay date: 24 Apr 2026
Submitted: 20 May 2026
Quarter: 2026-Q2
Submitter: d.aalto
Sample provenance: Buyer-sourced

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	99.48	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.52	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — O-desmethyl metabolite analogue (−14 Da)	0.23	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	624.2181	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	624.2157	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-3.9	ppm	± 10	PASS
Total peptide content	by difference from the gravimetric mass balance	80.76	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	80.34	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	330.99	mg	250 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	265.917	mg	250 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	106.4	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.16	%	≤ 10.0	PASS
Counter-ion (mesylate)	anion-exchange ion chromatography	15.84	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.24	%	—	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	White cake, partially collapsed	—	white to off-white intact cake	FAIL
Reconstitution clarity	reconstituted per submitter procedure	Clear, colourless, no visible particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.32	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	14.10	min	13.86 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.10	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	60,918	—	≥ 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 60,918, and skew follows the reported asymmetry factor of 1.10. 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 0.23 % impurity against a 99.48 % 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	14.10	4,835,036	99.48	—
2	O-desmethyl metabolite analogue (−14 Da)	13.58	11,179	0.23	-14.016
3	spiroindane regioisomer	14.54	9,721	0.20	0.000
4	sulfonamide hydrolysis product (+18 Da)	13.24	2,430	0.05	+18.011
5	free base (des-mesylate, −96 Da)	14.14	1,944	0.04	-96.011
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 3

Mass spectrum and identity

Theoretical monoisotopic mass 624.2181 Da, computed from C27H36N4O5S · CH4O3S. All ppm figures on this site are against monoisotopic values — see why that matters.

Figure 2. ESI charge-state envelope, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 624.2157 Da. Sodium (+21.982/z) and potassium (+37.956/z) adducts are shown where the parent charge state exceeds 25 % relative abundance; they are adducts of the same molecule and are not impurities.

Charge	Theoretical m/z	Observed m/z	Δ m/z	Rel. abundance (%)
2+	313.1163	313.1151	-0.0012	56.7
1+	625.2254	625.2230	-0.0024	100.0

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	3.16
Counter-ion (mesylate)	ion chromatography	15.84
Residual solvent + inorganic residue	estimated	0.24
Total peptide content	by difference	80.76
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)	99.31	99.48	divergence +0.17 pp vs batch median
Total impurities (% area)	0.69	0.52
Largest single impurity (% area)	0.25	0.23
Water (%)	3.0	3.16
Counter-ion (%)	7.4	15.84
Peptide content (%w/w)	89.0	80.76
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, 28 d) → laboratory (hand-carried, 5 d) → assay.
Assay date: 24 Apr 2026
Submitted to the index: 20 May 2026
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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.

gradient_2520 May 2026

The gradient is on the record, which is the first thing that should be true of any purity figure and often is not. 30 min at Janoshik puts this comparison on a documented footing.

schema_v220 May 2026

Both the theoretical and the observed monoisotopic mass are in the published dataset, so the ppm figure can be re-derived rather than trusted. That is the intent of publishing both.

lot_traceability20 May 2026

Lot TFS-{CAT}-1096 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 TFS-{CAT}-1096 n=3

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041733	TFS-{CAT}-1096	PeptideMeter	2026-Q2	99.07	3.93	95.1	Laboratory-retained	0	FAIL
AX-2026-041734	TFS-{CAT}-1096	PeptideMeter	2026-Q2	99.14	3.64	91.2	Buyer-sourced	0	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

All MK-677 (Ibutamoren mesylate) records n=143
All TFS records n=188
All Janoshik records n=2989
All 2026-Q2 records n=1126
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-2026-041734	TFS	TFS-{CAT}-1096	PeptideMeter	2026-Q2	99.14	3.64	91.2	Buyer-sourced	0	FAIL

Other recent TFS records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041681	CJC-1295 with DAC	TFS-{CAT}-9675	PeptideMeter	2026-Q3	98.82	3.67	—	Buyer-sourced	0	PASS
AX-2026-041766	BPC-157	TFS-{CAT}-1156	Janoshik	2026-Q3	99.54	6.34	—	Buyer-sourced	1	MARGINAL
AX-2026-041682	CJC-1295 with DAC	TFS-{CAT}-9675	Nordanalyt	2026-Q3	98.94	3.24	—	Buyer-sourced	0	PASS
AX-2026-041683	CJC-1295 with DAC	TFS-{CAT}-9675	Medutest	2026-Q3	98.68	3.46	97.0	Buyer-sourced	0	PASS
AX-2026-041765	BPC-157	TFS-{CAT}-1156	Janoshik	2026-Q3	99.79	6.01	—	Buyer-sourced	0	PASS
AX-2026-041680	CJC-1295 with DAC	TFS-{CAT}-9675	Medutest	2026-Q3	99.18	2.85	100.4	Buyer-sourced	0	PASS
AX-2026-041691	Semaglutide	TFS-{CAT}-9744	Janoshik	2026-Q2	98.31	6.07	91.4	Buyer-sourced	0	PASS
AX-2026-041700	SS-31 (Elamipretide)	TFS-{CAT}-1142	Medutest	2026-Q2	99.75	2.27	96.3	Buyer-sourced	0	PASS