AX-2025-021218

MK-677 (Ibutamoren mesylate) · 500 mg declared · PolyPeptide Group (Hangzhou) Co., Ltd. · lot PPG-2508-N7944

FAILPURITY ONLY

Report ID: AX-2025-021218
Compound: MK-677 (Ibutamoren mesylate)
Compound class: Non-peptide adjuncts
Supplier: PPG — PolyPeptide Group (Hangzhou) Co., Ltd.
Batch / lot: PPG-2508-N7944
Declared label claim: 500mg
Laboratory: Janoshik Analytical
Assay date: 20 Jul 2025
Submitted: 07 Aug 2025
Quarter: 2025-Q3
Submitter: ma.agyeman
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	99.49	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.51	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — sulfonamide hydrolysis product (+18 Da)	0.24	% 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	4.09	%	≤ 10.0	PASS
Counter-ion (mesylate)	anion-exchange ion chromatography	14.73	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.35	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	2.29	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 to pale-yellow cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Visible particulates, did not clear	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.34	—	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	1.11	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	49,430	—	≥ 20,000	PASS
Resolution to nearest impurity	vs free base (des-mesylate, −96 Da)	0.16	—	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 49,430, and skew follows the reported asymmetry factor of 1.11. 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 0.24 % impurity against a 99.49 % 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	4,835,522	99.49	—
2	sulfonamide hydrolysis product (+18 Da)	13.01	11,665	0.24	+18.011
3	residual DMF (process solvent)	5.67	5,346	0.11	-551.000
4	O-desmethyl metabolite analogue (−14 Da)	13.35	4,860	0.10	-14.016
5	free base (des-mesylate, −96 Da)	13.91	2,916	0.06	-96.011
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)	99.27	99.49	divergence -0.35 pp vs batch median
Total impurities (% area)	not stated	0.51
Largest single impurity (% area)	not stated	0.24
Water (%)	1.8	4.09
Counter-ion (%)	4.6	14.73
Peptide content (%w/w)	93.0	not determined
Endotoxin (EU/mg)	not stated	2.29
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 (2–8 °C, 14 d) → laboratory (courier, ambient, 2 d) → assay.
Assay date: 20 Jul 2025
Submitted to the index: 07 Aug 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.
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 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.

buyer_sourced07 Aug 2025

Independently purchased, at the submitter's own cost, forwarded without the supplier's involvement. That is the definition and this record meets it.

selection_bias07 Aug 2025

Provenance handles supplier selection. It does not handle submitter selection, which is the larger confounder and the one the index cannot measure.

desiccant_note07 Aug 2025

The packaging as received is part of the evidence on a retail purchase. Whether a desiccant was in the box is a fact about ordinary shipments, not about sample shipments.

baseline_noise07 Aug 2025

On a low-resolution pair the baseline between the peaks never reaches baseline, so any integration is an extrapolation. Stating which extrapolation was used is worth more than any threshold.

Section 7

Related records

Same batch — lot PPG-2508-N7944 n=4

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2025-021219	PPG-2508-N7944	Nordanalyt	2025-Q3	99.49	4.86	101.7	Buyer-sourced	FAIL
AX-2025-021220	PPG-2508-N7944	PeptideMeter	2025-Q3	99.92	4.65	—	Buyer-sourced	FAIL
AX-2025-021221	PPG-2508-N7944	Janoshik	2025-Q3	99.75	3.89	104.6	Buyer-sourced	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

All MK-677 (Ibutamoren mesylate) records n=143
All PPG records n=213
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 PPG records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043598	Tesamorelin	PPG-2608-A6835	Kestrel	2026-Q3	98.91	2.56	100.3	Buyer-sourced	1	FAIL
AX-2026-043597	Tesamorelin	PPG-2608-A6835	Janoshik	2026-Q3	98.54	1.15	—	Buyer-sourced	0	PASS
AX-2026-043596	Tesamorelin	PPG-2608-A6835	PeptideMeter	2026-Q3	98.74	1.83	105.1	Buyer-sourced	1	MARGINAL
AX-2026-043605	Retatrutide	PPG-2604-X7060	Janoshik	2026-Q2	98.17	4.29	99.7	Buyer-sourced	0	PASS
AX-2026-043601	Retatrutide	PPG-2604-X7060	Janoshik	2026-Q2	98.28	3.96	95.3	Buyer-sourced	0	PASS
AX-2026-043668	AOD-9604	PPG-2602-W8018	PeptideMeter	2026-Q2	99.47	3.06	—	Buyer-sourced	0	PASS
AX-2026-043670	AOD-9604	PPG-2602-W8018	PeptideMeter	2026-Q2	99.56	2.71	104.5	Buyer-sourced	0	PASS
AX-2026-043630	CJC-1295 (no DAC)	PPG-2512-D7211	Janoshik	2026-Q2	99.66	5.11	92.5	Buyer-sourced	0	PASS