AX-2026-042691 · TB-500 · ERP lot ERP-2511-L9306

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	99.37	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.63	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — [D-Thr]-diastereomer	0.42	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	887.4964	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	887.4985	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+2.4	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	90.24	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	89.67	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	10.69	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.586	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	95.9	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.24	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.12	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.40	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.84	EU/mg	≤ 5.0	PASS
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
Appearance	visual, diffuse light, black and white background	White cake, partial shrinkage from vial wall	—	white to off-white intact cake	FAIL
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	5.63	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	6.64	min	6.65 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.07	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	71,099	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Thr]-diastereomer	0.90	—	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 71,099, and skew follows the reported asymmetry factor of 1.07. 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 0.42 % impurity against a 99.37 % 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	6.64	4,829,690	99.37	—
2	[D-Thr]-diastereomer	6.55	20,413	0.42	0.000
3	des-acetyl TB-500 (−42 Da)	6.21	5,832	0.12	-42.011
4	C-terminal amide (−1 Da)	6.79	2,430	0.05	-0.984
5	des-Gln truncate (−128 Da)	6.44	1,944	0.04	-128.059
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, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 887.4985 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	444.7565	0.0010	60.9
1+	888.5037	888.5058	0.0021	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	5.24
Counter-ion (acetate)	ion chromatography	4.12
Residual solvent + inorganic residue	estimated	0.40
Total peptide content	by difference	90.24
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)	98.57	99.37	divergence -0.67 pp vs batch median
Total impurities (% area)	1.43	0.63
Largest single impurity (% area)	0.92	0.42
Water (%)	4.6	5.24
Counter-ion (%)	3.4	4.12
Peptide content (%w/w)	97.0	90.24
Endotoxin (EU/mg)	not stated	0.84
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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Domestic warehouse despatch → submitter (2–8 °C, 3 d) → laboratory (courier, cold pack, 9 d) → assay.
Assay date: 20 Dec 2025
Submitted to the index: 14 Jan 2026
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.
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.

diode_array14 Jan 2026

Photodiode-array spectral homogeneity across the main peak would convert 99.37 % from a good number into a checked one. It is a free measurement on any instrument that already has the detector.

area_percent14 Jan 2026

Purity at 99.37 % and water at 5.24 %: the two numbers are independent and both are needed. Excellent chromatography on a wet cake still yields less peptide per vial than the label implies.

schema_v214 Jan 2026

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.

lot_traceability14 Jan 2026

Lot ERP-2511-L9306 on the vial matches the certificate that came with it. That is the check every buyer can do in ten seconds and most do not.

Section 7

Related records

Same batch — lot ERP-2511-L9306 n=7

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020133	ERP-2511-L9306	Janoshik	2025-Q4	99.24	5.24	—	Buyer-sourced	1	MARGINAL
AX-2026-042692	ERP-2511-L9306	Janoshik	2025-Q4	98.76	5.22	—	Laboratory-retained	1	MARGINAL
AX-2026-042693	ERP-2511-L9306	Janoshik	2025-Q4	99.28	4.69	99.0	Buyer-sourced	1	MARGINAL
AX-2025-020134	ERP-2511-L9306	PeptideMeter	2025-Q4	98.93	4.68	—	Buyer-sourced	2	MARGINAL
AX-2025-020135	ERP-2511-L9306	Kestrel	2025-Q4	99.93	5.41	—	Supplier-supplied	1	MARGINAL
AX-2025-020136	ERP-2511-L9306	VendorInvestigate	2025-Q4	98.89	5.17	88.7	Buyer-sourced	2	MARGINAL

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 ERP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042706	Survodutide	ERP-2605-E9865	PeptideMeter	2026-Q3	98.38	5.33	103.5	Buyer-sourced	0	PASS
AX-2026-042704	Tesamorelin	ERP-2604-W9463	Janoshik	2026-Q3	99.02	4.08	—	Buyer-sourced	1	MARGINAL
AX-2026-042705	Survodutide	ERP-2605-E9865	Janoshik	2026-Q3	98.24	5.36	92.3	Buyer-sourced	0	PASS
AX-2026-042708	GHK-Cu	ERP-2601-F9816	Nordanalyt	2026-Q2	98.88	3.87	91.5	Buyer-sourced	1	MARGINAL
AX-2026-042694	Liraglutide	ERP-2601-P8985	Kestrel	2026-Q2	99.25	4.35	107.3	Buyer-sourced	1	MARGINAL
AX-2026-042707	GHK-Cu	ERP-2601-F9816	Janoshik	2026-Q2	98.53	4.70	96.3	Buyer-sourced	1	MARGINAL
AX-2026-042711	GHK-Cu	ERP-2601-F9816	Kestrel	2026-Q2	98.53	3.84	89.7	Laboratory-retained	2	MARGINAL
AX-2026-042722	Tirzepatide	ERP-2512-T9616	Medutest	2026-Q2	99.18	2.07	—	Buyer-sourced	1	MARGINAL