AX-2025-018656 · MK-677 (Ibutamoren mesylate) · QSC lot QSC-2507-F5673

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	99.63	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.37	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — sulfonamide hydrolysis product (+18 Da)	0.25	% 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	79.67	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	79.38	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	1274.92	mg	1000 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	1012.031	mg	1000 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	101.2	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.05	%	≤ 10.0	PASS
Counter-ion (mesylate)	anion-exchange ion chromatography	15.43	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.85	%	—	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 lyophilised cake, intact	—	white to off-white intact cake	PASS
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	5.19	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	13.87	min	13.86 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.15	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	62,398	—	≥ 20,000	PASS
Resolution to nearest impurity	vs free base (des-mesylate, −96 Da)	0.18	—	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 62,398, and skew follows the reported asymmetry factor of 1.15. 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 0.25 % impurity against a 99.63 % 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	13.87	4,842,327	99.63	—
2	sulfonamide hydrolysis product (+18 Da)	13.01	12,151	0.25	+18.011
3	free base (des-mesylate, −96 Da)	13.91	3,888	0.08	-96.011
4	O-desmethyl metabolite analogue (−14 Da)	13.35	972	0.02	-14.016
5	spiroindane regioisomer	14.31	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	4.05
Counter-ion (mesylate)	ion chromatography	15.43
Residual solvent + inorganic residue	estimated	0.85
Total peptide content	by difference	79.67
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)	99.90	99.63	divergence +0.16 pp vs batch median
Total impurities (% area)	0.10	0.37
Largest single impurity (% area)	0.06	0.25
Water (%)	4.2	4.05
Counter-ion (%)	3.3	15.43
Peptide content (%w/w)	97.9	79.67
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 (−20 °C, 16 d) → laboratory (courier, dry ice, 7 d) → assay.
Assay date: 02 Sep 2025
Submitted to the index: 21 Sep 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 4

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.

wide_iqr21 Sep 2025

A single result at 99.63 % is one draw. What makes a supplier's process legible is the spread across its lots, and that is on the scorecard rather than here. This record is one good point in a distribution worth reading whole.

lot_traceability21 Sep 2025

Lot QSC-2507-F5673 decodes to a manufacture date consistent with the custody chain above. Traceability plus 99.63 % is a complete story; either alone is half of one.

valley_drop21 Sep 2025

sulfonamide hydrolysis product (+18 Da) at 0.25 % elutes close enough to the main peak that drop-line and valley-to-valley will not agree. The index prints the resolution figure and applies no criterion to it — how close the nearest impurity sits is a property of the compound and the gradient, not of the system. What matters is that the convention used is stated.

spec_vs_result21 Sep 2025

A balance that closes says nothing about whether any of the four values is within specification. Consistency and compliance are different properties and this record demonstrates the first.

Section 7

Related records

Same batch — lot QSC-2507-F5673 n=11

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-018646	QSC-2507-F5673	Kestrel	2025-Q3	99.65	4.78	—	Buyer-sourced	1	FAIL
AX-2025-018647	QSC-2507-F5673	PeptideMeter	2025-Q3	99.79	4.29	—	Buyer-sourced	1	FAIL
AX-2025-018648	QSC-2507-F5673	Janoshik	2025-Q3	99.72	4.26	—	Buyer-sourced	1	FAIL
AX-2025-018649	QSC-2507-F5673	Nordanalyt	2025-Q3	99.79	4.54	107.3	Laboratory-retained	1	FAIL
AX-2025-018650	QSC-2507-F5673	Janoshik	2025-Q3	99.61	4.34	—	Buyer-sourced	1	FAIL
AX-2025-018651	QSC-2507-F5673	Janoshik	2025-Q3	99.74	4.21	99.5	Laboratory-retained	1	FAIL
AX-2025-018652	QSC-2507-F5673	Janoshik	2025-Q3	99.52	4.27	—	Buyer-sourced	1	FAIL
AX-2025-018653	QSC-2507-F5673	Nordanalyt	2025-Q3	99.87	4.46	94.9	Buyer-sourced	1	FAIL
AX-2025-018654	QSC-2507-F5673	PeptideMeter	2025-Q3	99.79	4.78	105.4	Buyer-sourced	1	FAIL
AX-2025-018655	QSC-2507-F5673	Janoshik	2025-Q3	99.78	4.37	94.8	Buyer-sourced	1	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

All MK-677 (Ibutamoren mesylate) records n=143
All QSC records n=350
All Janoshik records n=2989
All 2025-Q3 records n=816
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 QSC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041599	CJC-1295 (no DAC)	QSC-2606-V7416	VendorInvestigate	2026-Q3	97.96	3.52	—	Buyer-sourced	1	FAIL
AX-2026-041601	CJC-1295 (no DAC)	QSC-2606-V7416	Kestrel	2026-Q3	98.33	4.10	—	Buyer-sourced	1	MARGINAL
AX-2026-041602	CJC-1295 (no DAC)	QSC-2606-V7416	VendorInvestigate	2026-Q3	98.36	3.38	101.8	Buyer-sourced	1	MARGINAL
AX-2026-041477	Triptorelin	QSC-2607-C5749	Nordanalyt	2026-Q3	99.53	3.42	—	Buyer-sourced	0	PASS
AX-2026-041600	CJC-1295 (no DAC)	QSC-2606-V7416	Nordanalyt	2026-Q3	97.74	4.91	100.9	Buyer-sourced	1	FAIL
AX-2026-041603	CJC-1295 (no DAC)	QSC-2606-V7416	PeptideMeter	2026-Q3	98.43	4.20	—	Buyer-sourced	1	MARGINAL
AX-2026-041606	CJC-1295 (no DAC)	QSC-2606-V7416	Janoshik	2026-Q3	98.03	3.58	—	Buyer-sourced	1	MARGINAL
AX-2026-041585	Liraglutide	QSC-2605-W7381	Medutest	2026-Q3	99.59	5.09	92.8	Laboratory-retained	0	PASS