AX-2025-019799 · MK-677 (Ibutamoren mesylate) · Homopeptide lot HOMO-2506-L4686

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, 15 min gradient, 214 nm	99.93	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.07	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — free base (des-mesylate, −96 Da)	0.04	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	1.74	%	≤ 10.0	PASS
Counter-ion (mesylate)	anion-exchange ion chromatography	13.76	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.39	%	—	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	5.31	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	7.81	min	7.48 ± 0.30 (normalised)	FAIL
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.19	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	79,666	—	≥ 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, 15 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 79,666, and skew follows the reported asymmetry factor of 1.19. 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 0.04 % impurity against a 99.93 % 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	7.81	4,856,908	99.93	—
2	free base (des-mesylate, −96 Da)	7.83	1,944	0.04	-96.011
3	spiroindane regioisomer	8.03	1,458	0.03	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.

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	99.93	divergence -0.03 pp vs batch median
Total impurities (% area)	0.10	0.07
Largest single impurity (% area)	0.04	0.04
Water (%)	0.8	1.74
Counter-ion (%)	not stated	13.76
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	not stated	not determined
Method stated on certificate	NO	—	no method section — the result cannot be reconciled against any other

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, 31 d) → laboratory (courier, cold pack, 7 d) → assay.
Assay date: 03 Nov 2025
Submitted to the index: 10 Nov 2025
Laboratory: Kestrel Bioanalytical, Melbourne, Australia
Method basis: 15 min gradient · unit-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.
How much of the named compound is in the vial. Peptide content was not determined, so recovered mass cannot be calculated and the label claim cannot be checked.
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.

storage_stated10 Nov 2025

Purity 99.93 %, water 1.74 %, counter-ion 13.76 % mesylate, mass balance closed, provenance independent. There is nothing outstanding on this record.

coa_reader10 Nov 2025

The certificate that arrives with a retail order is the certificate an ordinary buyer gets. Assessing it is assessing the real documentation practice rather than the sample-request one.

dedupe_logic10 Nov 2025

Two retail purchases of the same lot from different buyers are genuinely independent. Two aliquots of one purchase are not, and the index does not treat them as such.

valley_drop10 Nov 2025

Valley height relative to the smaller peak is the practical criterion an operator uses, and it is not on the report. Resolution is a proxy for it and an imperfect one on asymmetric pairs.

Section 7

Related records

Same batch — lot HOMO-2506-L4686 n=13

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019787	HOMO-2506-L4686	Janoshik	2025-Q4	99.93	1.81	91.7	Buyer-sourced	0	FAIL
AX-2025-019788	HOMO-2506-L4686	Janoshik	2025-Q4	99.72	1.45	—	Buyer-sourced	0	FAIL
AX-2025-019789	HOMO-2506-L4686	Medutest	2025-Q4	99.93	1.59	—	Buyer-sourced	0	FAIL
AX-2025-019790	HOMO-2506-L4686	Medutest	2025-Q4	99.93	1.09	—	Buyer-sourced	1	FAIL
AX-2025-019791	HOMO-2506-L4686	VendorInvestigate	2025-Q4	99.70	1.37	102.4	Buyer-sourced	0	FAIL
AX-2025-019792	HOMO-2506-L4686	Janoshik	2025-Q4	99.89	1.40	95.5	Buyer-sourced	0	FAIL
AX-2025-019793	HOMO-2506-L4686	Janoshik	2025-Q4	99.51	1.23	—	Buyer-sourced	0	FAIL
AX-2025-019794	HOMO-2506-L4686	PeptideMeter	2025-Q4	99.93	1.59	—	Buyer-sourced	0	FAIL
AX-2025-019795	HOMO-2506-L4686	PeptideMeter	2025-Q4	99.93	1.31	103.3	Buyer-sourced	0	FAIL
AX-2025-019796	HOMO-2506-L4686	Janoshik	2025-Q4	99.93	1.00	—	Buyer-sourced	1	FAIL
AX-2025-019797	HOMO-2506-L4686	Janoshik	2025-Q4	99.80	1.22	105.9	Buyer-sourced	0	FAIL
AX-2025-019798	HOMO-2506-L4686	Medutest	2025-Q4	99.93	1.34	—	Buyer-sourced	1	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

All MK-677 (Ibutamoren mesylate) records n=143
All Homopeptide records n=457
All Kestrel records n=407
All 2025-Q4 records n=762
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 Homopeptide records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042437	Retatrutide	HOMO-2605-V4718	Nordanalyt	2026-Q3	98.68	3.67	102.8	Buyer-sourced	PASS
AX-2026-042424	Semaglutide	HOMO-2604-X3806	PeptideMeter	2026-Q3	98.85	4.87	92.0	Buyer-sourced	PASS
AX-2026-042503	IGF-1 LR3	HOMO-2607-P5131	Janoshik	2026-Q3	99.36	5.99	—	Buyer-sourced	PASS
AX-2026-042492	SS-31 (Elamipretide)	HOMO-2604-D5484	Medutest	2026-Q3	99.93	2.40	—	Buyer-sourced	PASS
AX-2026-042491	SS-31 (Elamipretide)	HOMO-2604-D5484	Kestrel	2026-Q3	99.93	3.24	—	Supplier-supplied	PASS
AX-2026-042473	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.01	5.00	—	Buyer-sourced	PASS
AX-2026-042441	Retatrutide	HOMO-2605-V4718	Medutest	2026-Q3	98.93	4.22	—	Buyer-sourced	PASS
AX-2026-042474	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.18	5.44	—	Buyer-sourced	PASS