AX-2025-019950 · TB-500 · HJ lot HJ-2501-A6454

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, 35 min gradient, 214 nm	99.48	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.52	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — des-Gln truncate (−128 Da)	0.23	% 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	89.78	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	89.31	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	11.37	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	10.155	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	101.5	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.74	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.63	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.85	%	—	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	4.55	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	9.17	min	9.07 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.05	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	50,773	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Thr]-diastereomer	0.77	—	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, 35 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 50,773, and skew follows the reported asymmetry factor of 1.05. 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 0.23 % impurity against a 99.48 % 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	9.17	4,835,036	99.48	—
2	des-Gln truncate (−128 Da)	8.89	11,179	0.23	-128.059
3	des-acetyl TB-500 (−42 Da)	8.56	8,263	0.17	-42.011
4	C-terminal amide (−1 Da)	9.38	2,916	0.06	-0.984
5	[D-Thr]-diastereomer	9.04	2,916	0.06	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	4.74
Counter-ion (acetate)	ion chromatography	4.63
Residual solvent + inorganic residue	estimated	0.85
Total peptide content	by difference	89.78
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)	99.5	99.48	divergence -0.08 pp vs batch median
Total impurities (% area)	0.50	0.52
Largest single impurity (% area)	0.21	0.23
Water (%)	3.1	4.74
Counter-ion (%)	not stated	4.63
Peptide content (%w/w)	not stated	89.78
Endotoxin (EU/mg)	not stated	not determined
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: Retail purchase → submitter (ambient, 15 d) → laboratory (hand-carried, 7 d) → assay.
Assay date: 12 Jan 2025
Submitted to the index: 25 Jan 2025
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 min gradient · high-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 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.

lambda_21425 Jan 2025

At 214 nm the amide bond dominates the response, so a peptide impurity is seen roughly in proportion to its size. 99.48 % on this detection is the conservative reading; a 280 nm trace would flatter it.

quarter_over_quarter25 Jan 2025

If a rounding convention changes mid-series the certificates become non-comparable across the change. Worth checking the timeline page before pooling declared figures from different quarters.

bland_altman25 Jan 2025

Where two laboratories tested the same retail lot, the paired difference is a clean estimate of inter-lab bias with no selection term in it at all. Those pairs are the backbone of the agreement analysis.

coa_template25 Jan 2025

The document that arrived with this order is on file and its fields are scored on the supplier's documentation rubric. That score describes what a buyer receives, which is the useful version.

Section 7

Related records

Same batch — lot HJ-2501-A6454 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019951	HJ-2501-A6454	Nordanalyt	2025-Q1	99.41	4.80	—	Buyer-sourced	1	MARGINAL
AX-2025-019952	HJ-2501-A6454	Janoshik	2025-Q1	99.50	4.43	93.1	Buyer-sourced	1	MARGINAL
AX-2025-019953	HJ-2501-A6454	Janoshik	2025-Q1	99.93	4.67	105.4	Supplier-supplied	1	MARGINAL
AX-2025-019954	HJ-2501-A6454	Janoshik	2025-Q1	99.66	4.95	90.1	Buyer-sourced	1	MARGINAL
AX-2025-019955	HJ-2501-A6454	Janoshik	2025-Q1	99.69	4.40	—	Buyer-sourced	1	MARGINAL
AX-2025-019956	HJ-2501-A6454	Kestrel	2025-Q1	99.80	4.88	98.6	Laboratory-retained	2	FAIL
AX-2025-019957	HJ-2501-A6454	PeptideMeter	2025-Q1	99.48	4.62	—	Buyer-sourced	1	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 HJ records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042595	Semaglutide	HJ-2608-C7002	Janoshik	2026-Q3	99.50	3.55	—	Buyer-sourced	1	MARGINAL
AX-2026-042598	Semaglutide	HJ-2608-C7002	Janoshik	2026-Q3	99.59	3.84	—	Buyer-sourced	0	PASS
AX-2026-042605	Semaglutide	HJ-2608-C7002	Janoshik	2026-Q3	99.03	3.37	107.3	Buyer-sourced	0	PASS
AX-2026-042602	Semaglutide	HJ-2608-C7002	Nordanalyt	2026-Q3	99.21	3.50	92.0	Buyer-sourced	0	PASS
AX-2026-042603	Semaglutide	HJ-2608-C7002	Janoshik	2026-Q3	99.16	3.42	105.9	Buyer-sourced	0	PASS
AX-2026-042528	GHRP-6	HJ-2603-R5329	VendorInvestigate	2026-Q3	98.69	1.87	95.8	Buyer-sourced	0	FAIL
AX-2026-042526	GHRP-6	HJ-2603-R5329	Medutest	2026-Q3	99.37	3.06	—	Laboratory-retained	0	PASS
AX-2026-042527	GHRP-6	HJ-2603-R5329	VendorInvestigate	2026-Q3	99.21	2.77	93.2	Buyer-sourced	0	PASS