AX-2024-004741 · TB-500 · Homopeptide lot HOMO-2308-R3867

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, 15 min gradient, 214 nm	99.46	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.54	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — des-Gln truncate (−128 Da)	0.21	% 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	90.73	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	90.24	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	10.18	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.186	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	91.9	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.60	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.43	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.24	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
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	4.36	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	4.30	min	4.24 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.99	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	85,418	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Thr]-diastereomer	0.91	—	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, 15 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 85,418, and skew follows the reported asymmetry factor of 0.99. 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 0.21 % impurity against a 99.46 % 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	TB-500 — main peak	4.30	4,834,064	99.46	—
2	des-Gln truncate (−128 Da)	4.18	10,207	0.21	-128.059
3	des-acetyl TB-500 (−42 Da)	4.04	7,776	0.16	-42.011
4	C-terminal amide (−1 Da)	4.39	4,374	0.09	-0.984
5	[D-Thr]-diastereomer	4.25	3,888	0.08	0.000
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	3.60
Counter-ion (acetate)	ion chromatography	5.43
Residual solvent + inorganic residue	estimated	0.24
Total peptide content	by difference	90.73
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)	99.36	99.46	divergence -0.07 pp vs batch median
Total impurities (% area)	0.64	0.54
Largest single impurity (% area)	not stated	0.21
Water (%)	not stated	3.60
Counter-ion (%)	2.2	5.43
Peptide content (%w/w)	93.7	90.73
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 (2–8 °C, 11 d) → laboratory (courier, ambient, 7 d) → assay.
Assay date: 29 Feb 2024
Submitted to the index: 13 Mar 2024
Laboratory: Kestrel Bioanalytical, Melbourne, Australia
Method basis: 15 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 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.

area_percent13 Mar 2024

Area percent assumes unit response factors across every species present. At 99.46 % the assumption barely matters — there is not enough impurity for a response-factor error to move the figure by a tenth.

moq_reality13 Mar 2024

Retail purchases test the retail channel. Manufacturer-tier material bought at kilogram scale is a different product with different documentation, and this index sees very little of it.

Section 7

Related records

Same batch — lot HOMO-2308-R3867 n=13

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004735	HOMO-2308-R3867	Nordanalyt	2024-Q1	99.41	3.70	—	Buyer-sourced	0	PASS
AX-2024-004736	HOMO-2308-R3867	Janoshik	2024-Q1	99.43	2.99	106.9	Buyer-sourced	0	PASS
AX-2024-004737	HOMO-2308-R3867	PeptideMeter	2024-Q1	99.49	3.86	101.5	Buyer-sourced	0	PASS
AX-2024-004738	HOMO-2308-R3867	VendorInvestigate	2024-Q1	99.21	3.26	—	Buyer-sourced	0	PASS
AX-2024-004739	HOMO-2308-R3867	Janoshik	2024-Q1	99.46	3.21	98.2	Buyer-sourced	0	PASS
AX-2024-004740	HOMO-2308-R3867	Janoshik	2024-Q1	99.33	3.34	100.5	Buyer-sourced	0	PASS
AX-2024-004742	HOMO-2308-R3867	PeptideMeter	2024-Q1	99.54	3.72	101.3	Laboratory-retained	0	PASS
AX-2024-004743	HOMO-2308-R3867	Janoshik	2024-Q1	99.70	3.40	88.9	Buyer-sourced	1	MARGINAL
AX-2024-004744	HOMO-2308-R3867	Janoshik	2024-Q1	99.43	3.41	92.9	Buyer-sourced	0	PASS
AX-2024-004745	HOMO-2308-R3867	Janoshik	2024-Q1	99.29	3.35	104.2	Buyer-sourced	0	PASS
AX-2024-004746	HOMO-2308-R3867	Nordanalyt	2024-Q1	99.41	3.21	106.9	Buyer-sourced	0	PASS
AX-2024-004747	HOMO-2308-R3867	PeptideMeter	2024-Q1	99.51	3.41	92.5	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent TB-500 records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041776	ASY	ASY-{CAT}-2167	Janoshik	2026-Q3	99.92	4.61	98.2	Buyer-sourced	0	PASS
AX-2026-041777	ASY	ASY-{CAT}-2167	PeptideMeter	2026-Q3	99.78	4.09	92.8	Buyer-sourced	0	PASS
AX-2026-041782	ASY	ASY-{CAT}-2167	Nordanalyt	2026-Q3	99.93	3.94	—	Buyer-sourced	0	PASS
AX-2026-041774	ASY	ASY-{CAT}-2167	PeptideMeter	2026-Q3	99.93	4.41	96.2	Buyer-sourced	0	PASS
AX-2026-042127	JEEP	JEEP-2602-V8614	Medutest	2026-Q3	99.68	3.55	—	Buyer-sourced	1	FAIL
AX-2026-042021	AMB	AMB-2602-P5987	VendorInvestigate	2026-Q3	99.86	4.79	101.4	Buyer-sourced	0	PASS
AX-2026-041780	ASY	ASY-{CAT}-2167	Janoshik	2026-Q3	99.93	3.48	102.5	Buyer-sourced	1	FAIL
AX-2026-041779	ASY	ASY-{CAT}-2167	Janoshik	2026-Q3	99.84	3.85	—	Buyer-sourced	1	FAIL

Other recent Homopeptide records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042437	Retatrutide	HOMO-2605-V4718	Nordanalyt	2026-Q3	98.68	3.67	102.8	Buyer-sourced	PASS
AX-2026-042424	Semaglutide	HOMO-2604-X3806	PeptideMeter	2026-Q3	98.85	4.87	92.0	Buyer-sourced	PASS
AX-2026-042503	IGF-1 LR3	HOMO-2607-P5131	Janoshik	2026-Q3	99.36	5.99	—	Buyer-sourced	PASS
AX-2026-042492	SS-31 (Elamipretide)	HOMO-2604-D5484	Medutest	2026-Q3	99.93	2.40	—	Buyer-sourced	PASS
AX-2026-042491	SS-31 (Elamipretide)	HOMO-2604-D5484	Kestrel	2026-Q3	99.93	3.24	—	Supplier-supplied	PASS
AX-2026-042473	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.01	5.00	—	Buyer-sourced	PASS
AX-2026-042441	Retatrutide	HOMO-2605-V4718	Medutest	2026-Q3	98.93	4.22	—	Buyer-sourced	PASS
AX-2026-042474	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.18	5.44	—	Buyer-sourced	PASS