AX-2025-020885 · 5-Amino-1MQ · WXT lot WXT-2505-M2430

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, 25 min gradient, 214 nm	99.08	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.92	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — 5-nitro-1MQ (unreduced precursor, +30 Da)	0.58	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	285.9967	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	285.9980	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+4.5	ppm	± 10	PASS
Total peptide content	by difference from the gravimetric mass balance	58.78	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	58.24	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	152.98	mg	100 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	89.096	mg	100 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	89.1	%	90.0 – 110.0	FAIL
Water content	Karl Fischer, coulometric, duplicate	2.46	%	≤ 10.0	PASS
Counter-ion (iodide)	anion-exchange ion chromatography	37.90	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.86	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
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 with a single visible fibre	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.89	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	4.56	min	4.59 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.91	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	73,996	—	≥ 20,000	PASS
Resolution to nearest impurity	vs free iodide (counter-ion, by IC)	0.00	—	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, 25 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 73,996, and skew follows the reported asymmetry factor of 0.91. 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 0.58 % impurity against a 99.08 % 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	5-Amino-1MQ — main peak	4.56	4,815,595	99.08	—
2	5-nitro-1MQ (unreduced precursor, +30 Da)	5.13	28,190	0.58	+29.974
3	1-methylquinolinium (des-amino, −15 Da)	4.29	7,776	0.16	-15.011
4	8-amino regioisomer	4.74	6,318	0.13	0.000
5	free iodide (counter-ion, by IC)	4.56	2,430	0.05	0.000
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 285.9967 Da, computed from C10H11N2+ · I−. All ppm figures on this site are against monoisotopic values — see why that matters.

Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 285.9980 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 (%)
1+	287.0040	287.0053	0.0013	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.

Component	Determination	%w/w of cake
Water	Karl Fischer	2.46
Counter-ion (iodide)	ion chromatography	37.90
Residual solvent + inorganic residue	estimated	0.86
Total peptide content	by difference	58.78
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)	99.09	99.08	divergence +0.38 pp vs batch median
Total impurities (% area)	0.91	0.92
Largest single impurity (% area)	0.51	0.58
Water (%)	not stated	2.46
Counter-ion (%)	7.9	37.90
Peptide content (%w/w)	88.0	58.78
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 6 d) → assay. Submitter did not handle the vial.
Assay date: 14 Apr 2025
Submitted to the index: 15 Apr 2025
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 min gradient · unit-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

That the compound is not a near-isobaric alternative. Identity was confirmed at unit mass resolution, which cannot exclude species differing by 1 or 2 Da. The specific alternatives not excluded are named in the identity block above.
That the material is free of bacterial endotoxin. Endotoxin was not measured. No chromatographic result bears on it.
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.

ppm_error15 Apr 2025

Well inside class limit. Worth noting that the class limits are set by mass rather than globally, because the same ppm is a different number of daltons at 340 and at 4,800.

ms_confirm15 Apr 2025

Two instruments or it is not confirmed, and this record is one instrument. It is a good one instrument, and the index records it as confirmed rather than corroborated for that reason.

plate_count15 Apr 2025

Where the plate count is low the resolution figure is low for a reason that has nothing to do with the impurity profile. Read the two together or read neither.

label_claim15 Apr 2025

A vial declared at 100 mg gross containing a cake of 58.24 %w/w target content yields exactly what the arithmetic says. Nothing here is unexpected once the basis is known; it is the basis that is usually missing.

Section 7

Related records

Same batch — lot WXT-2505-M2430 n=9

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020883	WXT-2505-M2430	Janoshik	2025-Q2	98.71	2.66	90.2	Buyer-sourced	0	FAIL
AX-2025-020884	WXT-2505-M2430	Medutest	2025-Q2	98.74	2.93	102.5	Buyer-sourced	0	FAIL
AX-2025-020886	WXT-2505-M2430	Nordanalyt	2025-Q2	99.34	2.77	98.0	Supplier-supplied	0	FAIL
AX-2025-020887	WXT-2505-M2430	Janoshik	2025-Q2	98.19	2.78	—	Buyer-sourced	0	FAIL
AX-2025-020888	WXT-2505-M2430	Janoshik	2025-Q2	98.51	2.75	89.4	Buyer-sourced	1	FAIL
AX-2025-020889	WXT-2505-M2430	VendorInvestigate	2025-Q2	97.98	2.57	—	Buyer-sourced	0	FAIL
AX-2025-020890	WXT-2505-M2430	Medutest	2025-Q2	98.27	2.90	100.5	Buyer-sourced	0	FAIL
AX-2025-020891	WXT-2505-M2430	VendorInvestigate	2025-Q2	98.80	3.32	104.8	Buyer-sourced	0	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent 5-Amino-1MQ records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043050	KP	KP-2511-W5347	Janoshik	2026-Q2	99.35	4.16	105.5	Buyer-sourced	0	FAIL
AX-2026-043044	KP	KP-2511-W5347	PeptideMeter	2026-Q2	99.61	4.15	90.9	Buyer-sourced	0	FAIL
AX-2026-043052	KP	KP-2511-W5347	Medutest	2026-Q2	99.45	4.23	105.5	Buyer-sourced	1	FAIL
AX-2026-043045	KP	KP-2511-W5347	Janoshik	2026-Q2	99.47	4.08	—	Buyer-sourced	0	FAIL
AX-2026-043043	KP	KP-2511-W5347	Janoshik	2026-Q2	99.58	4.16	101.1	Buyer-sourced	0	FAIL
AX-2026-042869	GGPeps	GGPE-2512-M2434	Kestrel	2026-Q2	99.55	4.65	103.9	Buyer-sourced	0	FAIL
AX-2026-042868	GGPeps	GGPE-2512-M2434	PeptideMeter	2026-Q2	99.32	4.39	88.5	Buyer-sourced	1	FAIL
AX-2026-043047	KP	KP-2511-W5347	Janoshik	2026-Q2	99.68	4.17	104.0	Supplier-supplied	0	FAIL

Other recent WXT records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043376	Semaglutide	WXT-2604-C3248	Janoshik	2026-Q3	97.08	4.22	—	Buyer-sourced	1	MARGINAL
AX-2026-043429	L-Glutathione (reduced)	WXT-2605-B3833	Nordanalyt	2026-Q3	98.48	6.58	96.9	Supplier-supplied	1	FAIL
AX-2026-043347	Leuprolide	WXT-2604-K2596	PeptideMeter	2026-Q3	99.16	5.99	93.6	Buyer-sourced	0	PASS
AX-2026-043353	Leuprolide	WXT-2604-K2596	Janoshik	2026-Q3	99.19	4.90	95.3	Laboratory-retained	0	PASS
AX-2026-043345	Leuprolide	WXT-2604-K2596	Janoshik	2026-Q3	98.93	5.28	—	Buyer-sourced	0	PASS
AX-2026-043424	L-Glutathione (reduced)	WXT-2605-B3833	PeptideMeter	2026-Q3	98.37	6.86	—	Buyer-sourced	0	FAIL
AX-2026-043374	Semaglutide	WXT-2604-C3248	Janoshik	2026-Q3	97.00	3.56	—	Buyer-sourced	1	MARGINAL
AX-2026-043377	Semaglutide	WXT-2604-C3248	PeptideMeter	2026-Q3	97.20	4.08	—	Buyer-sourced	1	MARGINAL