AX-2024-004747 · 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, 28 min gradient, 214 nm	99.51	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.49	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — des-Gln truncate (−128 Da)	0.19	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	887.4964	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	887.4959	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-0.6	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	90.54	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	90.10	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	10.27	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.253	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	92.5	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.41	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.70	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.35	%	—	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	5.73	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 28 min gradient	7.46	min	7.38 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.02	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	83,995	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Thr]-diastereomer	0.97	—	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, 28 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 83,995, and skew follows the reported asymmetry factor of 1.02. 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 0.19 % impurity against a 99.51 % 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	7.46	4,836,494	99.51	—
2	des-Gln truncate (−128 Da)	7.24	9,235	0.19	-128.059
3	des-acetyl TB-500 (−42 Da)	6.97	7,290	0.15	-42.011
4	C-terminal amide (−1 Da)	7.63	3,888	0.08	-0.984
5	[D-Thr]-diastereomer	7.36	3,402	0.07	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 3

Mass spectrum and identity

Theoretical monoisotopic mass 887.4964 Da, computed from C39H69N9O14. 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 887.4959 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+	444.7555	444.7552	-0.0003	54.4
1+	888.5037	888.5032	-0.0005	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	3.41
Counter-ion (acetate)	ion chromatography	5.70
Residual solvent + inorganic residue	estimated	0.35
Total peptide content	by difference	90.54
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	99.51	divergence -0.07 pp vs batch median
Total impurities (% area)	0.64	0.49
Largest single impurity (% area)	not stated	0.19
Water (%)	not stated	3.41
Counter-ion (%)	2.2	5.70
Peptide content (%w/w)	93.7	90.54
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, 22 d) → laboratory (hand-carried, 3 d) → assay.
Assay date: 25 Jan 2024
Submitted to the index: 26 Jan 2024
Laboratory: PeptideMeter, Tallinn, Estonia
Method basis: 28 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 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.

uncertainty_budget26 Jan 2024

Expanded uncertainty on a well-resolved main peak is about ±0.48 pp at 95 % confidence. 99.51 % should be read as a band, and the band is still comfortably above the class specification.

schema_v226 Jan 2024

Both the theoretical and the observed monoisotopic mass are in the published dataset, so the ppm figure can be re-derived rather than trusted. That is the intent of publishing both.

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-2024-004741	HOMO-2308-R3867	Kestrel	2024-Q1	99.46	3.60	91.9	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

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