AX-2025-020625 · 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, 15 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 — sulfonamide hydrolysis product (+18 Da)	0.49	% 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	82.00	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	81.34	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	572.60	mg	500 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	465.753	mg	500 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	93.2	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.88	%	≤ 10.0	PASS
Counter-ion (mesylate)	anion-exchange ion chromatography	12.78	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.34	%	—	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 to pale-yellow cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Clear with a single visible fibre	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.35	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	7.48	min	7.48 ± 0.30 (normalised)	PASS
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	67,449	—	≥ 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, 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 67,449, 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 0.49 % 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	7.48	4,821,428	99.20	—
2	sulfonamide hydrolysis product (+18 Da)	7.05	23,816	0.49	+18.011
3	free base (des-mesylate, −96 Da)	7.50	9,235	0.19	-96.011
4	spiroindane regioisomer	7.70	2,430	0.05	0.000
5	residual DMF (process solvent)	3.38	1,944	0.04	-551.000
6	O-desmethyl metabolite analogue (−14 Da)	7.22	1,458	0.03	-14.016
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	4.88
Counter-ion (mesylate)	ion chromatography	12.78
Residual solvent + inorganic residue	estimated	0.34
Total peptide content	by difference	82.00
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)	99.03	99.20	divergence +0.15 pp vs batch median
Total impurities (% area)	0.97	0.80
Largest single impurity (% area)	0.41	0.49
Water (%)	3.9	4.88
Counter-ion (%)	not stated	12.78
Peptide content (%w/w)	not stated	82.00
Endotoxin (EU/mg)	0.45	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: Domestic warehouse despatch → submitter (2–8 °C, 19 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date: 19 Jun 2025
Submitted to the index: 25 Jun 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.
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.

osmolality_chk25 Jun 2025

Total dissolved solids on reconstitution should reconcile with the balance. Where it does not, the discrepancy is usually an undissolved fraction rather than a measurement error.

salt_exchange25 Jun 2025

Incomplete salt exchange leaves two counter-ions in the cake and only one gets measured. That is the commonest way a real balance acquires a genuine remainder.

endotoxin_limit25 Jun 2025

If this material is going anywhere near a cell culture, endotoxin is the parameter that will ruin the experiment before purity does. That is a laboratory-planning point rather than a finding about the lot.

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-2025-020622	GLBI-2501-Y7989	PeptideMeter	2025-Q2	98.52	5.49	—	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

Batch rollup and reproducibility assessment →

Cross-sections

All MK-677 (Ibutamoren mesylate) records n=143
All GL Biochem records n=83
All Kestrel records n=407
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