AX-2026-043523

MK-677 (Ibutamoren mesylate) · 500 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2511-G7276

FAILPURITY ONLY

Report ID: AX-2026-043523
Compound: MK-677 (Ibutamoren mesylate)
Compound class: Non-peptide adjuncts
Supplier: BCH — Bachem Holding (Suzhou) Co., Ltd.
Batch / lot: BCH-2511-G7276
Declared label claim: 500mg
Laboratory: Janoshik Analytical
Assay date: 10 Apr 2026
Submitted: 26 Apr 2026
Quarter: 2026-Q2
Submitter: k.nascimento
Sample provenance: Supplier-supplied

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	98.21	% area	≥ 98.5	FAIL
Total impurities	RP-HPLC, sum of reported peaks	1.79	% area	≤ 1.5	FAIL
Largest single impurity	RP-HPLC — spiroindane regioisomer	1.12	% area	≤ 1.00	FAIL
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	4.31	%	≤ 10.0	PASS
Counter-ion (mesylate)	anion-exchange ion chromatography	12.88	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.42	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.48	EU/mg	≤ 5.0	PASS
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
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	4.42	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	13.79	min	13.86 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.31	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	72,072	—	≥ 20,000	PASS
Resolution to nearest impurity	vs free base (des-mesylate, −96 Da)	0.19	—	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 72,072, and skew follows the reported asymmetry factor of 1.31. 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 1.12 % impurity against a 98.21 % 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	13.79	4,773,310	98.21	—
2	spiroindane regioisomer	14.23	54,435	1.12	0.000
3	free base (des-mesylate, −96 Da)	13.83	19,927	0.41	-96.011
4	sulfonamide hydrolysis product (+18 Da)	12.93	5,832	0.12	+18.011
5	residual DMF (process solvent)	5.59	3,888	0.08	-551.000
6	O-desmethyl metabolite analogue (−14 Da)	13.27	2,916	0.06	-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.

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)	98.61	98.21	divergence +0.26 pp vs batch median
Total impurities (% area)	1.39	1.79
Largest single impurity (% area)	0.99	1.12
Water (%)	not stated	4.31
Counter-ion (%)	not stated	12.88
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	0.37	0.48
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 2 d) → assay. Submitter did not handle the vial.
Assay date: 10 Apr 2026
Submitted to the index: 26 Apr 2026
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 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

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot BCH-2511-G7276 n=13

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043521	BCH-2511-G7276	Medutest	2026-Q2	98.43	4.78	—	Supplier-supplied	2	FAIL
AX-2026-043522	BCH-2511-G7276	Janoshik	2026-Q2	98.13	4.21	96.8	Supplier-supplied	1	FAIL
AX-2026-043524	BCH-2511-G7276	Janoshik	2026-Q2	98.36	4.68	—	Supplier-supplied	1	FAIL
AX-2026-043525	BCH-2511-G7276	Medutest	2026-Q2	98.37	4.32	—	Buyer-sourced	1	FAIL
AX-2026-043526	BCH-2511-G7276	Medutest	2026-Q2	97.60	4.50	—	Buyer-sourced	1	FAIL
AX-2026-043527	BCH-2511-G7276	Janoshik	2026-Q2	98.35	4.36	95.5	Supplier-supplied	1	FAIL
AX-2026-043528	BCH-2511-G7276	Janoshik	2026-Q2	98.35	4.90	—	Supplier-supplied	1	FAIL
AX-2026-043529	BCH-2511-G7276	Janoshik	2026-Q2	98.35	4.48	101.5	Supplier-supplied	1	FAIL
AX-2026-043530	BCH-2511-G7276	PeptideMeter	2026-Q2	98.55	4.28	88.8	Supplier-supplied	2	FAIL
AX-2026-043531	BCH-2511-G7276	Janoshik	2026-Q2	98.59	4.34	—	Supplier-supplied	1	FAIL
AX-2026-043532	BCH-2511-G7276	Janoshik	2026-Q2	98.18	4.32	—	Laboratory-retained	1	FAIL
AX-2026-043533	BCH-2511-G7276	VendorInvestigate	2026-Q2	97.96	5.07	—	Buyer-sourced	1	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

All MK-677 (Ibutamoren mesylate) records n=152
All BCH records n=316
All Janoshik records n=3159
All 2026-Q2 records n=1009
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-2026-043524	BCH	BCH-2511-G7276	Janoshik	2026-Q2	98.36	4.68	—	Supplier-supplied	1	FAIL
AX-2026-041764	FGP	FGP-2604-K1470	Janoshik	2026-Q2	99.93	5.34	—	Supplier-supplied	1	FAIL
AX-2026-043527	BCH	BCH-2511-G7276	Janoshik	2026-Q2	98.35	4.36	95.5	Supplier-supplied	1	FAIL
AX-2026-042409	SWB	SWB-2605-B4738	Medutest	2026-Q2	99.32	2.99	94.9	Laboratory-retained	1	FAIL
AX-2026-043526	BCH	BCH-2511-G7276	Medutest	2026-Q2	97.60	4.50	—	Buyer-sourced	1	FAIL
AX-2026-042410	SWB	SWB-2605-B4738	Janoshik	2026-Q2	99.61	2.81	—	Supplier-supplied	1	FAIL
AX-2026-041765	FGP	FGP-2604-K1470	Janoshik	2026-Q2	99.93	5.08	—	Supplier-supplied	0	FAIL
AX-2026-043525	BCH	BCH-2511-G7276	Medutest	2026-Q2	98.37	4.32	—	Buyer-sourced	1	FAIL

Other recent BCH records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043574	N-Acetyl Semax Amide	BCH-2602-E8253	Janoshik	2026-Q3	97.75	8.85	97.9	Supplier-supplied	1	FAIL
AX-2026-043503	BPC-157	BCH-2603-G6422	Janoshik	2026-Q3	98.46	4.32	—	Supplier-supplied	1	MARGINAL
AX-2026-043575	N-Acetyl Semax Amide	BCH-2602-E8253	Janoshik	2026-Q3	97.44	9.19	104.8	Supplier-supplied	1	FAIL
AX-2026-043539	CJC-1295 with DAC	BCH-2607-H7307	Janoshik	2026-Q3	98.12	5.78	100.6	Supplier-supplied	1	MARGINAL
AX-2026-043504	BPC-157	BCH-2603-G6422	Janoshik	2026-Q3	98.38	4.45	95.5	Supplier-supplied	1	MARGINAL
AX-2026-043502	BPC-157	BCH-2603-G6422	PeptideMeter	2026-Q3	97.72	4.86	—	Buyer-sourced	1	FAIL
AX-2026-043501	BPC-157	BCH-2603-G6422	PeptideMeter	2026-Q3	98.37	4.75	100.8	Supplier-supplied	1	MARGINAL
AX-2026-043573	N-Acetyl Semax Amide	BCH-2602-E8253	Janoshik	2026-Q3	97.47	8.59	—	Supplier-supplied	1	FAIL