AX-2026-042149 · Thymulin · JEEP lot JEEP-2602-T8987

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	99.68	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.32	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — des-Ser truncate (−87 Da)	0.16	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	873.3716	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	873.3755	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+4.5	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	88.06	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	87.78	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.27	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	1.993	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	99.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.34	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.82	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.78	%	—	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	6.58	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	5.50	min	5.60 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.87	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	43,938	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.39	—	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 43,938, and skew follows the reported asymmetry factor of 0.87. 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 0.16 % impurity against a 99.68 % 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	Thymulin — main peak	5.50	4,844,757	99.68	—
2	des-Ser truncate (−87 Da)	5.27	7,776	0.16	-87.032
3	diketopiperazine (−18 Da)	5.68	3,402	0.07	-18.011
4	zinc-free apo-thymulin	5.17	2,430	0.05	-63.929
5	deamidated (+1 Da)	5.35	1,944	0.04	+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 3

Mass spectrum and identity

Theoretical monoisotopic mass 873.3716 Da, computed from C35H55N9O17. 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 873.3755 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 (%)
2+	437.6931	437.6950	0.0019	55.4
1+	874.3789	874.3828	0.0039	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	5.34
Counter-ion (acetate)	ion chromatography	5.82
Residual solvent + inorganic residue	estimated	0.78
Total peptide content	by difference	88.06
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	99.68	divergence +0.15 pp vs batch median
Total impurities (% area)	not stated	0.32
Largest single impurity (% area)	not stated	0.16
Water (%)	4.1	5.34
Counter-ion (%)	not stated	5.82
Peptide content (%w/w)	91.1	88.06
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: Laboratory-retained
Evidentiary weight: Provenance documented, selection uncontrolled.
Chain of custody: Laboratory retained sample (−20 °C, 34 d since original receipt) → re-assay.
Assay date: 13 Mar 2026
Submitted to the index: 29 Mar 2026
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 min gradient · unit-resolution MS
Verification status: PARTIAL

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 the material is sterile. Sterility was not tested.
How much metal is present. The mobile phase dissociates the complex on-column, so the peptide was measured and the metal was not. A purity figure for a metal-complexed peptide without a separate metal determination is half of a result.
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.

prep_hplc_cut29 Mar 2026

0.32 % total impurities on Thymulin means the preparative fraction was cut narrow. That trades yield for purity, and the trade was made in the buyer's favour on this lot.

fill_homogeneity29 Mar 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.

Section 7

Related records

Same batch — lot JEEP-2602-T8987 n=2

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042150	JEEP-2602-T8987	Janoshik	2026-Q1	99.81	4.75	—	Laboratory-retained	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Thymulin records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041219	WWB	WWB-2602-S2129	PeptideMeter	2026-Q2	99.20	4.00	94.0	Buyer-sourced	0	PASS
AX-2026-041216	WWB	WWB-2602-S2129	Kestrel	2026-Q2	99.00	3.45	—	Buyer-sourced	0	PASS
AX-2026-041215	WWB	WWB-2602-S2129	Nordanalyt	2026-Q2	99.27	3.86	104.9	Buyer-sourced	0	PASS
AX-2026-041218	WWB	WWB-2602-S2129	Janoshik	2026-Q2	99.40	3.93	90.9	Buyer-sourced	0	PASS
AX-2026-041221	WWB	WWB-2602-S2129	Nordanalyt	2026-Q2	99.54	4.16	99.4	Buyer-sourced	0	PASS
AX-2026-041223	WWB	WWB-2602-S2129	Janoshik	2026-Q2	99.23	3.78	—	Buyer-sourced	0	PASS
AX-2026-041222	WWB	WWB-2602-S2129	VendorInvestigate	2026-Q2	99.14	3.36	105.7	Buyer-sourced	0	PASS
AX-2026-041214	WWB	WWB-2602-S2129	PeptideMeter	2026-Q2	99.29	4.61	101.9	Buyer-sourced	1	MARGINAL

Other recent JEEP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042177	Hexarelin	JEEP-2608-Y9547	Janoshik	2026-Q3	99.90	3.42	—	Buyer-sourced	0	PASS
AX-2026-042162	Semaglutide	JEEP-2607-X9091	Janoshik	2026-Q3	98.98	3.46	—	Laboratory-retained	1	MARGINAL
AX-2026-042127	TB-500	JEEP-2602-V8614	Medutest	2026-Q3	99.68	3.55	—	Buyer-sourced	1	FAIL
AX-2026-042123	TB-500	JEEP-2602-V8614	PeptideMeter	2026-Q3	99.93	3.80	—	Buyer-sourced	0	PASS
AX-2026-042124	TB-500	JEEP-2602-V8614	PeptideMeter	2026-Q3	99.91	3.37	104.9	Buyer-sourced	0	PASS
AX-2026-042178	Hexarelin	JEEP-2608-Y9547	VendorInvestigate	2026-Q3	99.68	4.03	—	Buyer-sourced	0	PASS
AX-2026-042163	Semaglutide	JEEP-2607-X9091	Nordanalyt	2026-Q3	99.46	4.52	—	Buyer-sourced	1	MARGINAL
AX-2026-042122	TB-500	JEEP-2602-V8614	PeptideMeter	2026-Q3	99.60	3.58	97.0	Buyer-sourced	0	PASS