AX-2024-005054

Thymosin α1 · 1.6 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2407-L6364

MARGINALIDENTITY CONSISTENT

Report ID: AX-2024-005054
Compound: Thymosin α1
Compound class: Tissue-repair and immunomodulatory peptides
Supplier: SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Batch / lot: SSA-2407-L6364
Declared label claim: 2mg
Laboratory: Medutest
Assay date: 19 Jul 2024
Submitted: 13 Aug 2024
Quarter: 2024-Q3
Submitter: b.delgado
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, 25 min gradient, 214 nm	98.22	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.78	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — deamidated Asn (+1 Da)	1.13	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	3106.5493	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	3106.5577	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+2.7	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	1.13	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.14	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.83	%	—	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	Off-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	6.02	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	10.65	min	10.77 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.16	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	49,177	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated Asn (+1 Da)	1.44	—	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 49,177, and skew follows the reported asymmetry factor of 1.16. 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 1.13 % impurity against a 98.22 % 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	10.65	4,773,796	98.22	—
2	deamidated Asn (+1 Da)	10.37	54,922	1.13	+0.984
3	truncated (1-24)	9.62	18,955	0.39	-487.229
4	des-acetyl Tα1 (−42 Da)	10.08	7,776	0.16	-42.011
5	aspartimide (−18 Da)	11.00	4,860	0.10	-18.011
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 3106.5493 Da, computed from C129H215N33O55. 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 3106.5577 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 (%)
5+	622.3171	622.3188	0.0017	8.7
4+	777.6446	777.6467	0.0021	53.8
3+	1036.5237	1036.5265	0.0028	100.0
2+	1554.2819	1554.2861	0.0042	58.3

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)	98.5	98.22	divergence +0.11 pp vs batch median
Total impurities (% area)	1.50	1.78
Largest single impurity (% area)	not stated	1.13
Water (%)	not stated	1.13
Counter-ion (%)	not stated	4.14
Peptide content (%w/w)	91.7	not determined
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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Retail purchase → submitter (ambient, 4 d) → laboratory (courier, cold pack, 2 d) → assay.
Assay date: 19 Jul 2024
Submitted to the index: 13 Aug 2024
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.
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 3

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.

lot_traceability13 Aug 2024

A retail vial at 98.22 % is worth more evidentially than a selected vial at a higher figure. That is the whole argument for recording provenance at all.

label_claim13 Aug 2024

A retail vial is also a test of the label. Declared claim 1.6 mg against what the gravimetry recovers is a question only a purchased vial can answer honestly.

valley_drop13 Aug 2024

Valley height relative to the smaller peak is the practical criterion an operator uses, and it is not on the report. Resolution is a proxy for it and an imperfect one on asymmetric pairs.

Section 7

Related records

Same batch — lot SSA-2407-L6364 n=6

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005049	SSA-2407-L6364	Janoshik	2024-Q3	98.70	1.48	104.2	Buyer-sourced	1	MARGINAL
AX-2024-005050	SSA-2407-L6364	Janoshik	2024-Q3	98.48	1.81	91.9	Buyer-sourced	1	MARGINAL
AX-2024-005051	SSA-2407-L6364	PeptideMeter	2024-Q3	98.29	1.46	98.9	Buyer-sourced	1	MARGINAL
AX-2024-005052	SSA-2407-L6364	PeptideMeter	2024-Q3	98.16	1.28	—	Buyer-sourced	1	MARGINAL
AX-2024-005053	SSA-2407-L6364	Janoshik	2024-Q3	98.85	1.52	—	Buyer-sourced	1	MARGINAL

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-2026-041999	AMB	AMB-2511-B5683	Medutest	2026-Q2	99.93	3.95	102.2	Supplier-supplied	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

Other recent SSA records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043135	BPC-157	SSA-2601-N6863	Nordanalyt	2026-Q2	98.16	4.66	92.8	Buyer-sourced	1	MARGINAL
AX-2026-043160	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.01	4.02	91.8	Buyer-sourced	0	PASS
AX-2026-043157	GHK-Cu	SSA-2604-V7731	Medutest	2026-Q2	99.19	5.14	—	Supplier-supplied	0	PASS
AX-2026-043141	BPC-157	SSA-2601-N6863	Janoshik	2026-Q2	98.06	4.06	94.6	Buyer-sourced	1	MARGINAL
AX-2026-043154	GHK-Cu	SSA-2604-V7731	PeptideMeter	2026-Q2	97.82	4.82	101.6	Buyer-sourced	0	PASS
AX-2026-043137	BPC-157	SSA-2601-N6863	PeptideMeter	2026-Q2	98.17	4.14	—	Buyer-sourced	1	MARGINAL
AX-2026-043162	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.50	4.36	—	Supplier-supplied	0	PASS
AX-2026-043134	BPC-157	SSA-2601-N6863	Medutest	2026-Q2	97.89	4.01	—	Buyer-sourced	1	FAIL