AX-2024-004990

MK-677 (Ibutamoren mesylate) · 500 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2408-L4573

FAILVERIFIED

Report ID: AX-2024-004990
Compound: MK-677 (Ibutamoren mesylate)
Compound class: Non-peptide adjuncts
Supplier: KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot: KP-2408-L4573
Declared label claim: 500mg
Laboratory: Janoshik Analytical
Assay date: 26 Aug 2024
Submitted: 02 Sep 2024
Quarter: 2024-Q3
Submitter: lu.krastev
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	99.30	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.70	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — sulfonamide hydrolysis product (+18 Da)	0.47	% 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)	624.2205	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+3.9	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	1.96	%	≤ 10.0	PASS
Counter-ion (mesylate)	anion-exchange ion chromatography	12.96	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.96	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	1.90	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	Off-white lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Clear after 90 s gentle swirling, no particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.09	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	13.57	min	13.86 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.92	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	60,660	—	≥ 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 60,660, and skew follows the reported asymmetry factor of 0.92. 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 0.47 % impurity against a 99.30 % 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	13.57	4,826,288	99.30	—
2	sulfonamide hydrolysis product (+18 Da)	12.71	22,843	0.47	+18.011
3	spiroindane regioisomer	14.01	5,832	0.12	0.000
4	O-desmethyl metabolite analogue (−14 Da)	13.05	2,916	0.06	-14.016
5	free base (des-mesylate, −96 Da)	13.61	1,458	0.03	-96.011
6	residual DMF (process solvent)	5.37	972	0.02	-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 624.2205 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	313.1175	0.0012	59.7
1+	625.2254	625.2278	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.

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	99.30	divergence +0.38 pp vs batch median
Total impurities (% area)	0.10	0.70
Largest single impurity (% area)	not stated	0.47
Water (%)	not stated	1.96
Counter-ion (%)	not stated	12.96
Peptide content (%w/w)	91.7	not determined
Endotoxin (EU/mg)	0.64	1.90
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, 17 d) → laboratory (courier, cold pack, 4 d) → assay.
Assay date: 26 Aug 2024
Submitted to the index: 02 Sep 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 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.

plate_count02 Sep 2024

Plate count on this run supports the separation claimed. A high purity figure from an inefficient column is a merged peak reported as a clean one; that is not what happened here.

quad_unit02 Sep 2024

Instrument class is on the record, which is what allows +3.9 ppm to be read at its proper weight. The index distinguishes "confirmed" from "consistent with" precisely on this field.

isotope_cluster02 Sep 2024

Nothing here rules out a positional isomer with the same formula. Mass cannot; only chromatography can, and the gradient length on this record is the relevant fact for that.

Section 7

Related records

Same batch — lot KP-2408-L4573 n=3

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004991	KP-2408-L4573	Nordanalyt	2024-Q3	99.52	3.05	—	Buyer-sourced	0	FAIL
AX-2024-004992	KP-2408-L4573	Medutest	2024-Q3	99.71	2.18	—	Laboratory-retained	1	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

All MK-677 (Ibutamoren mesylate) records n=143
All KP records n=223
All Janoshik records n=2989
All 2024-Q3 records n=464
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 KP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043095	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	95.81	5.48	105.2	Buyer-sourced	0	FAIL
AX-2026-043094	Retatrutide	KP-2607-H5774	PeptideMeter	2026-Q3	96.32	6.40	—	Buyer-sourced	0	FAIL
AX-2026-043096	Retatrutide	KP-2607-H5774	VendorInvestigate	2026-Q3	96.48	6.05	104.9	Buyer-sourced	0	FAIL
AX-2026-043090	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	96.46	5.81	—	Buyer-sourced	0	FAIL
AX-2026-043091	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	96.13	5.94	—	Buyer-sourced	0	FAIL
AX-2026-043077	TB-500	KP-2605-C5214	Janoshik	2026-Q2	99.61	5.64	90.2	Buyer-sourced	0	PASS
AX-2026-043093	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	96.54	5.54	—	Buyer-sourced	0	PASS
AX-2026-043092	Retatrutide	KP-2607-H5774	Medutest	2026-Q3	96.64	6.12	—	Buyer-sourced	1	FAIL