AX-2024-004628 · ARA-290 · TFC lot TFC-2410-N5362

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, 32 min gradient, 214 nm	99.43	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.57	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — [D-Ser]-diastereomer	0.40	% 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)	1189.6088	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-0.7	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	92.18	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	91.65	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	4.59	mg	4 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.207	mg	4 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	105.2	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.86	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	3.23	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.73	%	—	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	4.58	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 32 min gradient	9.34	min	9.25 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.93	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	69,089	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Ser]-diastereomer	0.88	—	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, 32 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 69,089, and skew follows the reported asymmetry factor of 0.93. 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 0.40 % impurity against a 99.43 % 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	9.34	4,832,606	99.43	—
2	[D-Ser]-diastereomer	9.21	19,441	0.40	0.000
3	acetyl adduct (+42 Da)	9.77	5,832	0.12	+42.011
4	deamidated (+1 Da)	9.11	1,458	0.03	+0.984
5	des-Gln truncate (−128 Da)	9.02	972	0.02	-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 1189.6088 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	397.5435	-0.0003	7.7
2+	595.8121	595.8117	-0.0004	53.7
1+	1190.6169	1190.6161	-0.0008	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	3.86
Counter-ion (acetate)	ion chromatography	3.23
Residual solvent + inorganic residue	estimated	0.73
Total peptide content	by difference	92.18
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)	99.90	99.43	divergence +0.09 pp vs batch median
Total impurities (% area)	0.10	0.57
Largest single impurity (% area)	not stated	0.40
Water (%)	3.4	3.86
Counter-ion (%)	not stated	3.23
Peptide content (%w/w)	not stated	92.18
Endotoxin (EU/mg)	0.30	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, 16 d) → laboratory (hand-carried, 5 d) → assay.
Assay date: 27 Oct 2024
Submitted to the index: 12 Nov 2024
Laboratory: VendorInvestigate, Riga, Latvia
Method basis: 32 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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

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 TFC-2410-N5362 n=10

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004625	TFC-2410-N5362	Janoshik	2024-Q4	99.93	3.67	96.0	Supplier-supplied	1	MARGINAL
AX-2024-004626	TFC-2410-N5362	PeptideMeter	2024-Q4	99.79	4.09	89.8	Supplier-supplied	2	MARGINAL
AX-2024-004627	TFC-2410-N5362	Medutest	2024-Q4	99.82	3.80	94.5	Supplier-supplied	1	MARGINAL
AX-2024-004629	TFC-2410-N5362	VendorInvestigate	2024-Q4	99.69	3.74	97.8	Buyer-sourced	1	MARGINAL
AX-2024-004630	TFC-2410-N5362	PeptideMeter	2024-Q4	99.25	3.51	94.2	Laboratory-retained	1	MARGINAL
AX-2024-004631	TFC-2410-N5362	PeptideMeter	2024-Q4	99.93	3.85	—	Supplier-supplied	1	MARGINAL
AX-2024-004632	TFC-2410-N5362	Janoshik	2024-Q4	99.93	4.00	—	Supplier-supplied	1	MARGINAL
AX-2025-019194	TFC-2410-N5362	Janoshik	2024-Q4	99.87	3.34	90.7	Supplier-supplied	1	MARGINAL
AX-2024-004633	TFC-2410-N5362	Medutest	2024-Q4	99.80	4.35	—	Laboratory-retained	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	Flags	Result
AX-2026-041852	JEEP	JEEP-2601-K3139	Janoshik	2026-Q2	99.03	4.60	—	Buyer-sourced	1	MARGINAL
AX-2026-043211	SGN	SGN-2605-X9661	PeptideMeter	2026-Q2	97.96	7.11	101.7	Supplier-supplied	1	FAIL
AX-2026-041857	JEEP	JEEP-2601-K3139	Kestrel	2026-Q2	99.09	4.21	—	Supplier-supplied	1	MARGINAL
AX-2026-043212	SGN	SGN-2605-X9661	PeptideMeter	2026-Q2	98.58	7.00	—	Supplier-supplied	1	MARGINAL
AX-2026-041853	JEEP	JEEP-2601-K3139	PeptideMeter	2026-Q2	98.50	4.51	94.7	Laboratory-retained	1	MARGINAL
AX-2026-041856	JEEP	JEEP-2601-K3139	Janoshik	2026-Q2	99.63	4.29	92.0	Supplier-supplied	1	MARGINAL
AX-2026-041851	JEEP	JEEP-2601-K3139	Janoshik	2026-Q2	99.00	4.51	—	Supplier-supplied	1	MARGINAL
AX-2026-041858	JEEP	JEEP-2601-K3139	VendorInvestigate	2026-Q2	98.82	4.14	—	Buyer-sourced	1	MARGINAL

Other recent TFC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041932	Semaglutide	TFC-2604-X4301	Janoshik	2026-Q3	98.88	4.31	—	Supplier-supplied	0	PASS
AX-2026-042067	SS-31 (Elamipretide)	TFC-2604-Y7472	Kestrel	2026-Q3	98.66	4.44	—	Supplier-supplied	1	MARGINAL
AX-2026-042057	Sermorelin	TFC-2605-Y6440	Janoshik	2026-Q3	98.68	3.94	98.3	Supplier-supplied	0	PASS
AX-2026-041936	Semaglutide	TFC-2604-X4301	PeptideMeter	2026-Q3	98.62	4.30	—	Buyer-sourced	1	MARGINAL
AX-2026-041973	Humanin (HNG)	TFC-2605-U5564	Janoshik	2026-Q3	99.62	7.03	—	Supplier-supplied	2	FAIL
AX-2026-041980	Humanin (HNG)	TFC-2605-U5564	Janoshik	2026-Q3	99.90	7.01	88.6	Supplier-supplied	2	MARGINAL
AX-2026-041961	Tirzepatide	TFC-2605-G5134	Medutest	2026-Q3	98.25	7.11	—	Supplier-supplied	2	MARGINAL
AX-2026-042068	SS-31 (Elamipretide)	TFC-2604-Y7472	Medutest	2026-Q3	98.71	3.63	92.9	Supplier-supplied	2	MARGINAL