AX-2025-020985

ARA-290 · 2 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2502-N3730

MARGINALIDENTITY CONSISTENT

Report ID: AX-2025-020985
Compound: ARA-290
Compound class: Tissue-repair and immunomodulatory peptides
Supplier: WXT — WuXi TIDES (WuXi AppTec Testing Division)
Batch / lot: WXT-2502-N3730
Declared label claim: 2mg
Laboratory: Janoshik Analytical
Assay date: 07 Jun 2025
Submitted: 25 Jun 2025
Quarter: 2025-Q2
Submitter: n.okonkwo
Sample provenance: Buyer-sourced

Section 1

Results

Measured against the index acceptance specification for the tissue-repair and immunomodulatory peptides 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	99.13	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.87	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — deamidated (+1 Da)	0.41	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	1189.6096	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	1189.6111	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+1.3	ppm	± 15	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	4.26	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.27	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.70	%	—	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 after 90 s gentle swirling, no particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.55	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	8.79	min	8.72 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.22	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	60,931	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Ser]-diastereomer	0.82	—	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 60,931, and skew follows the reported asymmetry factor of 1.22. 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 0.41 % impurity against a 99.13 % 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	ARA-290 — main peak	8.79	4,818,025	99.13	—
2	deamidated (+1 Da)	8.57	19,927	0.41	+0.984
3	[D-Ser]-diastereomer	8.67	15,553	0.32	0.000
4	acetyl adduct (+42 Da)	9.19	3,888	0.08	+42.011
5	des-Gln truncate (−128 Da)	8.49	2,916	0.06	-128.059
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 1189.6096 Da, computed from C50H83N15O18. All ppm figures on this site are against monoisotopic values — see why that matters.

Figure 2. ESI charge-state envelope, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 1189.6111 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 (%)
3+	397.5438	397.5443	0.0005	8.8
2+	595.8121	595.8128	0.0007	60.5
1+	1190.6169	1190.6184	0.0015	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.

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)	99.5	99.13	divergence +0.27 pp vs batch median
Total impurities (% area)	0.50	0.87
Largest single impurity (% area)	not stated	0.41
Water (%)	not stated	4.26
Counter-ion (%)	not stated	4.27
Peptide content (%w/w)	91.7	not determined
Endotoxin (EU/mg)	not stated	not determined
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 (−20 °C, 21 d) → laboratory (courier, dry ice, 7 d) → assay.
Assay date: 07 Jun 2025
Submitted to the index: 25 Jun 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

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 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 2

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.

one_directional25 Jun 2025

Direction is the thing to watch, not roundness. Rounded declarations in this index sit above and below the independent median at close to equal rates, which is what scatter looks like.

retest_date25 Jun 2025

Retail certificates in this index carry a retest date more often than they used to. It is the field that turns a release figure into a statement about the material over time.

Section 7

Related records

Same batch — lot WXT-2502-N3730 n=4

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020984	WXT-2502-N3730	PeptideMeter	2025-Q2	99.33	4.16	—	Buyer-sourced	1	MARGINAL
AX-2025-020986	WXT-2502-N3730	Janoshik	2025-Q2	99.93	3.35	—	Supplier-supplied	1	MARGINAL
AX-2025-020987	WXT-2502-N3730	PeptideMeter	2025-Q2	98.74	4.21	—	Buyer-sourced	1	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent ARA-290 records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-041767	ASY	ASY-{CAT}-1521	Janoshik	2026-Q3	99.66	4.42	103.7	Buyer-sourced	PASS
AX-2026-043222	SGN	SGN-2605-X9069	PeptideMeter	2026-Q2	98.32	7.36	—	Buyer-sourced	PASS
AX-2026-041907	SinoPep	SNP-2605-G4075	Janoshik	2026-Q2	99.20	5.75	—	Buyer-sourced	PASS
AX-2026-043227	SGN	SGN-2605-X9069	PeptideMeter	2026-Q2	98.38	7.21	95.6	Buyer-sourced	PASS
AX-2026-041862	GSP	GSP-2605-K3362	Janoshik	2026-Q2	99.34	3.32	—	Buyer-sourced	PASS
AX-2026-041906	SinoPep	SNP-2605-G4075	Medutest	2026-Q2	98.94	5.28	—	Buyer-sourced	PASS
AX-2026-042346	Homopeptide	HOMO-2601-T3123	PeptideMeter	2026-Q2	99.70	3.47	—	Buyer-sourced	PASS
AX-2026-043229	SGN	SGN-2605-X9069	Janoshik	2026-Q2	98.21	7.43	—	Buyer-sourced	PASS

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