AX-2025-021323

MK-677 (Ibutamoren mesylate) · 1000 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2510-P7418

FAILPURITY ONLY

Report ID: AX-2025-021323
Compound: MK-677 (Ibutamoren mesylate)
Compound class: Non-peptide adjuncts
Supplier: BCH — Bachem Holding (Suzhou) Co., Ltd.
Batch / lot: BCH-2510-P7418
Declared label claim: 1000mg
Laboratory: Janoshik Analytical
Assay date: 14 Oct 2025
Submitted: 28 Oct 2025
Quarter: 2025-Q4
Submitter: chain_custody
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	98.19	% area	≥ 98.5	FAIL
Total impurities	RP-HPLC, sum of reported peaks	1.81	% area	≤ 1.5	FAIL
Largest single impurity	RP-HPLC — O-desmethyl metabolite analogue (−14 Da)	0.81	% 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	82.14	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	80.65	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	1129.94	mg	1000 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	911.297	mg	1000 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	91.1	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.66	%	≤ 10.0	PASS
Counter-ion (mesylate)	anion-exchange ion chromatography	12.62	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.58	%	—	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	5.45	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	13.85	min	13.86 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.04	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	64,725	—	≥ 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 64,725, and skew follows the reported asymmetry factor of 1.04. 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 0.81 % impurity against a 98.19 % 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	13.85	4,772,338	98.19	—
2	O-desmethyl metabolite analogue (−14 Da)	13.33	39,369	0.81	-14.016
3	sulfonamide hydrolysis product (+18 Da)	12.99	32,564	0.67	+18.011
4	free base (des-mesylate, −96 Da)	13.89	9,721	0.20	-96.011
5	spiroindane regioisomer	14.29	3,888	0.08	0.000
6	residual DMF (process solvent)	5.65	2,430	0.05	-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 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	4.66
Counter-ion (mesylate)	ion chromatography	12.62
Residual solvent + inorganic residue	estimated	0.58
Total peptide content	by difference	82.14
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)	98.39	98.19	divergence +0.20 pp vs batch median
Total impurities (% area)	not stated	1.81
Largest single impurity (% area)	not stated	0.81
Water (%)	not stated	4.66
Counter-ion (%)	not stated	12.62
Peptide content (%w/w)	not stated	82.14
Endotoxin (EU/mg)	not stated	not determined
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, 2 d) → laboratory (courier, cold pack, 6 d) → assay.
Assay date: 14 Oct 2025
Submitted to the index: 28 Oct 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.
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.

shipping_temp28 Oct 2025

The custody block above records the shipping conditions this vial actually experienced, which is the condition an ordinary buyer's vial experiences too. That representativeness is the point.

baseline_noise28 Oct 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.

endotoxin_limit28 Oct 2025

Any buyer can order the test on their own vial for the price of a small order. It is the single most under-purchased measurement in this market.

Section 7

Related records

Same batch — lot BCH-2510-P7418 n=1

This is the only report on this lot. One report is not a batch characterisation.

Batch rollup and reproducibility assessment →

Cross-sections

All MK-677 (Ibutamoren mesylate) records n=139
All BCH records n=316
All Janoshik records n=3300
All 2025-Q4 records n=815
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-2026-041754	FGP	FGP-2604-K9878	Janoshik	2026-Q2	99.89	5.06	93.8	Buyer-sourced	0	FAIL
AX-2026-042619	SWB	SWB-2605-B6440	Janoshik	2026-Q2	99.30	3.05	—	Buyer-sourced	0	FAIL
AX-2026-041756	FGP	FGP-2604-K9878	Janoshik	2026-Q2	99.62	4.41	89.4	Buyer-sourced	1	FAIL
AX-2026-041751	FGP	FGP-2604-K9878	Janoshik	2026-Q2	99.79	5.69	88.7	Buyer-sourced	1	FAIL
AX-2026-043676	BCH	BCH-2511-G7498	Medutest	2026-Q2	98.86	4.81	99.6	Buyer-sourced	1	FAIL
AX-2026-043678	BCH	BCH-2511-G7498	Kestrel	2026-Q2	98.74	3.73	—	Buyer-sourced	0	FAIL
AX-2026-041753	FGP	FGP-2604-K9878	Janoshik	2026-Q2	99.93	5.72	88.7	Buyer-sourced	1	FAIL
AX-2026-043677	BCH	BCH-2511-G7498	Janoshik	2026-Q2	98.83	4.58	—	Supplier-supplied	0	FAIL

Other recent BCH records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043691	BPC-157	BCH-2603-L7768	Janoshik	2026-Q3	98.66	5.12	—	Supplier-supplied	1	MARGINAL
AX-2026-043693	BPC-157	BCH-2603-L7768	PeptideMeter	2026-Q3	97.82	5.21	94.9	Buyer-sourced	0	FAIL
AX-2026-043686	BPC-157	BCH-2603-L7768	VendorInvestigate	2026-Q3	97.64	5.27	—	Buyer-sourced	0	FAIL
AX-2026-043695	BPC-157	BCH-2603-L7768	Janoshik	2026-Q3	97.61	5.42	—	Buyer-sourced	0	FAIL
AX-2026-043726	N-Acetyl Semax Amide	BCH-2602-E8475	Janoshik	2026-Q3	97.89	9.67	104.2	Buyer-sourced	0	FAIL
AX-2026-043688	BPC-157	BCH-2603-L7768	Janoshik	2026-Q3	97.94	5.56	—	Buyer-sourced	0	FAIL
AX-2026-043658	BPC-157	BCH-2603-G6644	Janoshik	2026-Q3	98.45	4.37	101.8	Supplier-supplied	0	PASS
AX-2026-043692	BPC-157	BCH-2603-L7768	VendorInvestigate	2026-Q3	97.60	5.61	—	Buyer-sourced	0	FAIL