AX-2025-020864 · MK-677 (Ibutamoren mesylate) · CPC lot CPC-2503-G2382

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, 28 min gradient, 214 nm	98.66	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.34	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — free base (des-mesylate, −96 Da)	0.79	% 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	81.12	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	80.03	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	585.91	mg	500 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	468.904	mg	500 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	93.8	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.17	%	≤ 10.0	PASS
Counter-ion (mesylate)	anion-exchange ion chromatography	13.45	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.26	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.58	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 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	5.02	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 28 min gradient	12.98	min	13.01 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.00	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	54,869	—	≥ 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, 28 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 54,869, and skew follows the reported asymmetry factor of 1.00. 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 0.79 % impurity against a 98.66 % 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	12.98	4,795,182	98.66	—
2	free base (des-mesylate, −96 Da)	13.02	38,396	0.79	-96.011
3	sulfonamide hydrolysis product (+18 Da)	12.18	16,525	0.34	+18.011
4	spiroindane regioisomer	13.39	4,860	0.10	0.000
5	residual DMF (process solvent)	5.33	2,916	0.06	-551.000
6	O-desmethyl metabolite analogue (−14 Da)	12.49	2,430	0.05	-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	5.17
Counter-ion (mesylate)	ion chromatography	13.45
Residual solvent + inorganic residue	estimated	0.26
Total peptide content	by difference	81.12
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)	98.53	98.66	divergence -0.22 pp vs batch median
Total impurities (% area)	1.47	1.34
Largest single impurity (% area)	not stated	0.79
Water (%)	5.1	5.17
Counter-ion (%)	not stated	13.45
Peptide content (%w/w)	90.1	81.12
Endotoxin (EU/mg)	0.21	0.58
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: Retail purchase → submitter (ambient, 13 d) → laboratory (hand-carried, 6 d) → assay.
Assay date: 23 Jun 2025
Submitted to the index: 18 Jul 2025
Laboratory: PeptideMeter, Tallinn, Estonia
Method basis: 28 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 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_sourced18 Jul 2025

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

storage_stated18 Jul 2025

Stated storage conditions on the certificate against the observed transit conditions in the custody block: on this record they agree, which removes one class of explanation for anything unexpected.

epitalon_bAsp18 Jul 2025

A beta-aspartyl isomer sits a tenth of a minute away and is mass-identical. That is the archetype of a pair where resolution is a compound property and no rule should adjudicate it.

spec_vs_result18 Jul 2025

The class specification for counter-ion on this site is the index's own threshold and it is generous. A figure above it is a formulation observation rather than a defect.

Section 7

Related records

Same batch — lot CPC-2503-G2382 n=7

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020860	CPC-2503-G2382	Janoshik	2025-Q2	98.75	5.28	91.0	Buyer-sourced	1	FAIL
AX-2025-020861	CPC-2503-G2382	Janoshik	2025-Q2	98.85	5.55	—	Buyer-sourced	1	FAIL
AX-2025-020862	CPC-2503-G2382	Medutest	2025-Q2	98.56	5.37	93.9	Buyer-sourced	1	FAIL
AX-2025-020863	CPC-2503-G2382	Janoshik	2025-Q2	98.53	5.54	97.5	Buyer-sourced	1	FAIL
AX-2025-020865	CPC-2503-G2382	Janoshik	2025-Q2	98.89	5.08	—	Buyer-sourced	1	FAIL
AX-2025-020866	CPC-2503-G2382	Janoshik	2025-Q2	98.78	5.55	—	Buyer-sourced	1	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

All MK-677 (Ibutamoren mesylate) records n=143
All CPC records n=227
All PeptideMeter records n=1116
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 CPC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043319	BPC-157	CPC-2602-W1610	Medutest	2026-Q3	98.82	2.88	103.5	Buyer-sourced	2	MARGINAL
AX-2026-043295	Liraglutide	CPC-2602-G9942	Janoshik	2026-Q3	97.34	5.17	106.3	Buyer-sourced	0	FAIL
AX-2026-043288	Tirzepatide	CPC-2607-L1516	Janoshik	2026-Q3	96.89	5.11	101.1	Laboratory-retained	0	FAIL
AX-2026-043327	N-Acetyl Semax Amide	CPC-2602-D1905	Nordanalyt	2026-Q3	99.05	5.67	90.6	Buyer-sourced	1	FAIL
AX-2026-043328	N-Acetyl Semax Amide	CPC-2602-D1905	Janoshik	2026-Q3	99.49	6.83	100.9	Supplier-supplied	0	PASS
AX-2026-043257	L-Carnosine	CPC-2603-G9615	VendorInvestigate	2026-Q3	98.20	10.41	102.2	Buyer-sourced	0	FAIL
AX-2026-043297	Liraglutide	CPC-2602-G9942	Janoshik	2026-Q3	97.01	4.95	103.5	Buyer-sourced	0	FAIL
AX-2026-043331	N-Acetyl Semax Amide	CPC-2602-D1905	Janoshik	2026-Q3	99.46	6.22	—	Supplier-supplied	0	PASS