AX-2025-020622 · MK-677 (Ibutamoren mesylate) · GL Biochem lot GLBI-2501-Y7989

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, 28 min gradient, 214 nm	98.52	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.48	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — free base (des-mesylate, −96 Da)	0.87	% 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)	624.2182	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+0.1	ppm	± 10	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	5.49	%	≤ 10.0	PASS
Counter-ion (mesylate)	anion-exchange ion chromatography	13.55	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.26	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.43	EU/mg	≤ 5.0	PASS
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	5.59	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 28 min gradient	13.04	min	13.01 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.03	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	60,678	—	≥ 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, 28 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 60,678, and skew follows the reported asymmetry factor of 1.03. 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 0.87 % impurity against a 98.52 % 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	13.04	4,788,377	98.52	—
2	free base (des-mesylate, −96 Da)	13.08	42,285	0.87	-96.011
3	sulfonamide hydrolysis product (+18 Da)	12.24	18,469	0.38	+18.011
4	spiroindane regioisomer	13.45	5,346	0.11	0.000
5	O-desmethyl metabolite analogue (−14 Da)	12.55	2,916	0.06	-14.016
6	residual DMF (process solvent)	5.39	2,916	0.06	-551.000
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 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 624.2182 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	313.1164	0.0001	59.1
1+	625.2254	625.2255	0.0001	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.

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)	99.03	98.52	divergence +0.15 pp vs batch median
Total impurities (% area)	0.97	1.48
Largest single impurity (% area)	0.41	0.87
Water (%)	3.9	5.49
Counter-ion (%)	not stated	13.55
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	0.45	0.43
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 12 d) → assay. Submitter did not handle the vial.
Assay date: 21 Jun 2025
Submitted to the index: 10 Jul 2025
Laboratory: PeptideMeter, Tallinn, Estonia
Method basis: 28 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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 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.

hplc_ola10 Jul 2025

A longer gradient buys resolution on close-eluting pairs at a linear cost in run time. PeptideMeter ran 28 min here; the reference method runs 30, and the difference is visible in this figure.

lambda_28010 Jul 2025

If the nearest impurity carries an aromatic residue the parent lacks, dual-wavelength detection separates them without any chromatographic change at all. Cheap and underused.

plate_count10 Jul 2025

Efficiency is the lever that does not change selectivity, so it improves resolution without moving anything else. Longer column, smaller particle, or lower flow, in that order of cost.

Section 7

Related records

Same batch — lot GLBI-2501-Y7989 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020618	GLBI-2501-Y7989	PeptideMeter	2025-Q2	98.73	5.01	—	Buyer-sourced	1	FAIL
AX-2025-020619	GLBI-2501-Y7989	Nordanalyt	2025-Q2	98.93	5.11	—	Buyer-sourced	1	FAIL
AX-2025-020620	GLBI-2501-Y7989	PeptideMeter	2025-Q2	98.82	4.94	—	Buyer-sourced	1	FAIL
AX-2025-020621	GLBI-2501-Y7989	Janoshik	2025-Q2	99.11	5.07	106.9	Supplier-supplied	1	FAIL
AX-2025-020623	GLBI-2501-Y7989	Janoshik	2025-Q2	98.97	4.56	104.5	Supplier-supplied	1	FAIL
AX-2025-020624	GLBI-2501-Y7989	Janoshik	2025-Q2	98.69	4.68	—	Buyer-sourced	1	FAIL
AX-2025-020625	GLBI-2501-Y7989	Kestrel	2025-Q2	99.20	4.88	93.2	Buyer-sourced	1	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

All MK-677 (Ibutamoren mesylate) records n=143
All GL Biochem records n=83
All PeptideMeter records n=1116
All 2025-Q2 records n=619
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 GL Biochem records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043179	Kisspeptin-10	GLBI-2608-N7715	Medutest	2026-Q3	98.97	4.37	—	Buyer-sourced	1	MARGINAL
AX-2026-043178	Kisspeptin-10	GLBI-2608-N7715	Janoshik	2026-Q3	98.50	4.55	—	Buyer-sourced	1	MARGINAL
AX-2026-043166	L-Glutathione (reduced)	GLBI-2606-S7352	Janoshik	2026-Q3	99.01	8.84	105.4	Laboratory-retained	1	MARGINAL
AX-2026-043184	Kisspeptin-10	GLBI-2608-N7715	Janoshik	2026-Q3	98.99	3.63	100.6	Supplier-supplied	1	MARGINAL
AX-2026-043185	Kisspeptin-10	GLBI-2608-N7715	Medutest	2026-Q3	98.71	3.71	107.0	Buyer-sourced	1	MARGINAL
AX-2026-043165	L-Glutathione (reduced)	GLBI-2606-S7352	Medutest	2026-Q3	99.47	8.60	—	Supplier-supplied	1	MARGINAL
AX-2026-043182	Kisspeptin-10	GLBI-2608-N7715	Janoshik	2026-Q3	98.93	3.86	95.7	Buyer-sourced	1	MARGINAL
AX-2026-043183	Kisspeptin-10	GLBI-2608-N7715	PeptideMeter	2026-Q3	98.54	4.17	102.2	Buyer-sourced	1	MARGINAL