AX-2026-042876

TB-500 · 10 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2601-B2671

PASSPURITY ONLY

Report ID: AX-2026-042876
Compound: TB-500
Compound class: Tissue-repair and immunomodulatory peptides
Supplier: GGPeps — Nantong Guangyuan Chemical Co., Ltd.
Batch / lot: GGPE-2601-B2671
Declared label claim: 10mg
Laboratory: PeptideMeter
Assay date: 14 Jun 2026
Submitted: 10 Jul 2026
Quarter: 2026-Q2
Submitter: ka.roos
Sample provenance: Buyer-sourced

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	99.43	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.57	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — des-acetyl TB-500 (−42 Da)	0.22	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	4.24	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.25	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.27	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.40	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, partially collapsed	—	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	6.03	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 28 min gradient	7.45	min	7.38 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.25	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	55,173	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Thr]-diastereomer	0.79	—	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 55,173, and skew follows the reported asymmetry factor of 1.25. 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 0.22 % impurity against a 99.43 % 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	7.45	4,832,606	99.43	—
2	des-acetyl TB-500 (−42 Da)	6.96	10,693	0.22	-42.011
3	C-terminal amide (−1 Da)	7.62	7,290	0.15	-0.984
4	des-Gln truncate (−128 Da)	7.23	5,346	0.11	-128.059
5	[D-Thr]-diastereomer	7.35	4,374	0.09	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.

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)	99.60	99.43	divergence +0.01 pp vs batch median
Total impurities (% area)	0.40	0.57
Largest single impurity (% area)	not stated	0.22
Water (%)	2.8	4.24
Counter-ion (%)	not stated	4.25
Peptide content (%w/w)	98.0	not determined
Endotoxin (EU/mg)	not stated	0.40
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, 22 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date: 14 Jun 2026
Submitted to the index: 10 Jul 2026
Laboratory: PeptideMeter, Tallinn, Estonia
Method basis: 28 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.
How much of the named compound is in the vial. Peptide content was not determined, so recovered mass cannot be calculated and the label claim cannot be checked.
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.

baseline_noise10 Jul 2026

Baseline on this trace is flat enough that the reporting threshold is doing real work rather than hiding peaks in noise. That is a precondition for believing 99.43 % and it is not always met.

aspartimide10 Jul 2026

Aspartimide formation at an Asp-Gly or Asp-Ser motif shows up as a pair of late-eluting satellites. They are not present above the reporting threshold on this trace.

Section 7

Related records

Same batch — lot GGPE-2601-B2671 n=13

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042870	GGPE-2601-B2671	Janoshik	2026-Q2	99.21	4.45	88.9	Buyer-sourced	1	MARGINAL
AX-2026-042871	GGPE-2601-B2671	PeptideMeter	2026-Q2	99.93	4.85	89.7	Supplier-supplied	1	MARGINAL
AX-2026-042872	GGPE-2601-B2671	Medutest	2026-Q2	99.80	5.26	92.5	Buyer-sourced	0	PASS
AX-2026-042873	GGPE-2601-B2671	Janoshik	2026-Q2	99.30	4.92	103.1	Buyer-sourced	0	PASS
AX-2026-042874	GGPE-2601-B2671	Janoshik	2026-Q2	99.59	4.96	104.3	Buyer-sourced	0	PASS
AX-2026-042875	GGPE-2601-B2671	Nordanalyt	2026-Q2	99.57	4.05	—	Buyer-sourced	0	PASS
AX-2026-042877	GGPE-2601-B2671	Janoshik	2026-Q2	99.67	5.07	105.8	Buyer-sourced	0	PASS
AX-2026-042878	GGPE-2601-B2671	Janoshik	2026-Q2	99.77	4.87	—	Buyer-sourced	1	FAIL
AX-2026-042879	GGPE-2601-B2671	Medutest	2026-Q2	99.93	4.42	98.8	Supplier-supplied	0	PASS
AX-2026-042880	GGPE-2601-B2671	Janoshik	2026-Q2	99.25	4.89	—	Buyer-sourced	0	PASS
AX-2026-042881	GGPE-2601-B2671	Janoshik	2026-Q2	99.69	4.50	—	Buyer-sourced	0	PASS
AX-2026-042882	GGPE-2601-B2671	VendorInvestigate	2026-Q2	99.50	5.12	—	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 GGPeps records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042784	CJC-1295 (no DAC)	GGPE-2606-E1234	Medutest	2026-Q3	98.27	4.55	—	Buyer-sourced	PASS
AX-2026-042786	CJC-1295 (no DAC)	GGPE-2606-E1234	Janoshik	2026-Q3	98.22	3.77	—	Buyer-sourced	PASS
AX-2026-042858	Selank	GGPE-2603-J2447	VendorInvestigate	2026-Q3	98.87	8.85	99.4	Buyer-sourced	FAIL
AX-2026-042783	CJC-1295 (no DAC)	GGPE-2606-E1234	Janoshik	2026-Q3	98.22	4.45	90.6	Buyer-sourced	PASS
AX-2026-042757	Melanotan II	GGPE-2603-P1474	Janoshik	2026-Q3	99.54	6.78	92.0	Buyer-sourced	PASS
AX-2026-042785	CJC-1295 (no DAC)	GGPE-2606-E1234	PeptideMeter	2026-Q3	97.70	4.64	91.4	Buyer-sourced	FAIL
AX-2026-042756	Melanotan II	GGPE-2603-P1474	Nordanalyt	2026-Q3	99.17	7.04	—	Buyer-sourced	PASS
AX-2026-042755	Melanotan II	GGPE-2603-P1474	Nordanalyt	2026-Q3	99.25	6.58	90.4	Buyer-sourced	PASS