AX-2026-041999 · Thymosin α1 · AMB lot AMB-2511-B5683

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, 25 min gradient, 214 nm	99.93	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.07	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — aspartimide (−18 Da)	0.04	% 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	90.53	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	90.47	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	11.30	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	10.223	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	102.2	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.95	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.04	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.48	%	—	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 to pale-yellow 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	4.97	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	10.82	min	10.77 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.26	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	89,385	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated Asn (+1 Da)	1.91	—	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 89,385, and skew follows the reported asymmetry factor of 1.26. 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 0.04 % impurity against a 99.93 % 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	Thymosin α1 — main peak	10.82	4,856,908	99.93	—
2	aspartimide (−18 Da)	11.17	1,944	0.04	-18.011
3	deamidated Asn (+1 Da)	10.54	1,458	0.03	+0.984
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	3.95
Counter-ion (acetate)	ion chromatography	5.04
Residual solvent + inorganic residue	estimated	0.48
Total peptide content	by difference	90.53
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)	99.16	99.93	divergence +0.05 pp vs batch median
Total impurities (% area)	0.84	0.07
Largest single impurity (% area)	not stated	0.04
Water (%)	1.8	3.95
Counter-ion (%)	not stated	5.04
Peptide content (%w/w)	not stated	90.53
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 5 d) → assay. Submitter did not handle the vial.
Assay date: 11 May 2026
Submitted to the index: 23 May 2026
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 min gradient · unit-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 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 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.

fill_homogeneity23 May 2026

A high figure on one vial is a statement about one vial. The within-lot spread on the batch rollup is what tells you whether the bulk was well mixed, and it is the rarer and more useful number.

ms_confirm23 May 2026

Purity at 99.93 % with identity confirmed on the same submission is the combination worth having. Either alone leaves a question the other answers.

racemisation_ala23 May 2026

Epimerisation during activation produces a diastereomer that is mass-identical and only chromatographically separable. At this gradient length the separation exists, and 99.93 % is net of it.

cleavage_cocktail23 May 2026

Alkylation artefacts from a scavenger-poor cleavage would appear as a +58 or +76 family here. Absent, which says the cleavage was run properly.

Section 7

Related records

Same batch — lot AMB-2511-B5683 n=5

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-041995	AMB-2511-B5683	PeptideMeter	2026-Q2	98.86	4.00	104.5	Buyer-sourced	PASS
AX-2026-041996	AMB-2511-B5683	VendorInvestigate	2026-Q2	99.31	4.20	91.2	Buyer-sourced	PASS
AX-2026-041997	AMB-2511-B5683	PeptideMeter	2026-Q2	99.11	4.26	104.3	Buyer-sourced	PASS
AX-2026-041998	AMB-2511-B5683	Nordanalyt	2026-Q2	99.08	3.83	—	Buyer-sourced	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Thymosin α1 records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041996	AMB	AMB-2511-B5683	VendorInvestigate	2026-Q2	99.31	4.20	91.2	Buyer-sourced	0	PASS
AX-2026-041995	AMB	AMB-2511-B5683	PeptideMeter	2026-Q2	98.86	4.00	104.5	Buyer-sourced	0	PASS
AX-2026-041998	AMB	AMB-2511-B5683	Nordanalyt	2026-Q2	99.08	3.83	—	Buyer-sourced	0	PASS
AX-2026-043232	SGN	SGN-2512-Y9621	Janoshik	2026-Q2	99.42	6.88	89.1	Buyer-sourced	1	MARGINAL
AX-2026-041997	AMB	AMB-2511-B5683	PeptideMeter	2026-Q2	99.11	4.26	104.3	Buyer-sourced	0	PASS
AX-2026-041442	QYB	QYB-2511-V5408	Kestrel	2026-Q1	99.82	2.35	96.1	Buyer-sourced	0	PASS
AX-2026-041438	QYB	QYB-2511-V5408	Janoshik	2026-Q1	99.80	2.70	105.2	Buyer-sourced	0	PASS
AX-2026-041446	QYB	QYB-2511-V5408	PeptideMeter	2026-Q1	99.40	2.66	98.9	Buyer-sourced	0	PASS

Other recent AMB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042002	Semaglutide	AMB-2607-N6274	VendorInvestigate	2026-Q3	98.23	6.37	97.1	Buyer-sourced	1	MARGINAL
AX-2026-042012	GHRP-6	AMB-2603-S5667	Janoshik	2026-Q3	99.37	5.90	88.8	Laboratory-retained	1	MARGINAL
AX-2026-041974	Tirzepatide	AMB-2603-C5112	Nordanalyt	2026-Q3	98.20	3.41	—	Buyer-sourced	0	PASS
AX-2026-041975	Tirzepatide	AMB-2603-C5112	Medutest	2026-Q3	97.88	3.45	106.9	Laboratory-retained	0	PASS
AX-2026-042005	Semaglutide	AMB-2607-N6274	PeptideMeter	2026-Q3	98.09	6.48	98.6	Buyer-sourced	1	MARGINAL
AX-2026-042008	Epitalon	AMB-2602-Y6433	Janoshik	2026-Q3	99.30	8.75	105.1	Buyer-sourced	0	PASS
AX-2026-042021	TB-500	AMB-2602-P5987	VendorInvestigate	2026-Q3	99.86	4.79	101.4	Buyer-sourced	0	PASS
AX-2026-042015	GHRP-6	AMB-2603-S5667	Janoshik	2026-Q3	99.54	6.44	97.1	Buyer-sourced	0	PASS