AX-2025-019634 · BPC-157 · TFC lot TFC-2507-J2316

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	98.91	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.09	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — des-Gly truncate (−57 Da)	0.73	% 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	86.39	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	85.45	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	10.55	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.015	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	90.2	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.27	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	8.62	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.72	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	5.26	EU/mg	≤ 5.0	FAIL
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	4.68	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	8.20	min	8.14 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.96	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	65,238	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Val]-diastereomer	0.89	—	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 65,238, and skew follows the reported asymmetry factor of 0.96. 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 0.73 % impurity against a 98.91 % 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	BPC-157 — main peak	8.20	4,807,333	98.91	—
2	des-Gly truncate (−57 Da)	7.92	35,480	0.73	-57.021
3	pyroglutamate cyclisation (−17 Da)	8.46	12,151	0.25	-17.027
4	truncated (1-12)	7.40	2,916	0.06	-285.132
5	acetylated N-terminus (+42 Da)	8.60	1,458	0.03	+42.011
6	[D-Val]-diastereomer	8.08	972	0.02	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	4.27
Counter-ion (acetate)	ion chromatography	8.62
Residual solvent + inorganic residue	estimated	0.72
Total peptide content	by difference	86.39
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	98.91	divergence +0.54 pp vs batch median
Total impurities (% area)	0.50	1.09
Largest single impurity (% area)	0.36	0.73
Water (%)	3.2	4.27
Counter-ion (%)	not stated	8.62
Peptide content (%w/w)	98.1	86.39
Endotoxin (EU/mg)	not stated	5.26
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, 10 d) → laboratory (courier, ambient, 6 d) → assay.
Assay date: 19 Aug 2025
Submitted to the index: 11 Sep 2025
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 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 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.

lot_traceability11 Sep 2025

Lot TFC-2507-J2316 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.

buyer_sourced11 Sep 2025

Ordering under an unremarkable name and address is the whole method. It requires no cooperation from anybody and it produces the strongest evidence this index holds.

peak_integrator11 Sep 2025

Resolution to the nearest named impurity is reported on this record with no verdict attached, which is the correct handling. A threshold on that figure would penalise compounds for their own impurity profiles.

hplc_ola11 Sep 2025

Column temperature shifts selectivity by a few percent per ten degrees on peptides. Where two peaks are this close that is enough to matter and it is rarely on the report.

Section 7

Related records

Same batch — lot TFC-2507-J2316 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019631	TFC-2507-J2316	Janoshik	2025-Q3	98.85	4.11	—	Buyer-sourced	1	MARGINAL
AX-2025-019632	TFC-2507-J2316	PeptideMeter	2025-Q3	98.70	3.61	106.1	Buyer-sourced	2	FAIL
AX-2025-019633	TFC-2507-J2316	Janoshik	2025-Q3	98.69	3.59	—	Buyer-sourced	1	MARGINAL
AX-2025-019635	TFC-2507-J2316	Janoshik	2025-Q3	99.01	3.73	104.5	Buyer-sourced	1	MARGINAL
AX-2025-019636	TFC-2507-J2316	Nordanalyt	2025-Q3	99.11	3.52	102.7	Buyer-sourced	1	MARGINAL
AX-2025-019637	TFC-2507-J2316	Janoshik	2025-Q3	99.30	4.49	92.1	Buyer-sourced	2	FAIL
AX-2025-019638	TFC-2507-J2316	Janoshik	2025-Q3	99.39	4.14	—	Buyer-sourced	1	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent BPC-157 records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043319	CPC	CPC-2602-W1610	Medutest	2026-Q3	98.82	2.88	103.5	Buyer-sourced	2	MARGINAL
AX-2026-041766	TFS	TFS-{CAT}-1156	Janoshik	2026-Q3	99.54	6.34	—	Buyer-sourced	1	MARGINAL
AX-2026-043445	BCH	BCH-2603-G4350	Nordanalyt	2026-Q3	98.42	4.87	93.6	Buyer-sourced	1	MARGINAL
AX-2026-043440	BCH	BCH-2603-G4350	VendorInvestigate	2026-Q3	98.61	4.11	—	Buyer-sourced	1	MARGINAL
AX-2026-043442	BCH	BCH-2603-G4350	Janoshik	2026-Q3	98.65	4.78	—	Buyer-sourced	1	MARGINAL
AX-2026-043449	BCH	BCH-2603-G4350	Kestrel	2026-Q3	99.74	4.92	91.3	Supplier-supplied	2	MARGINAL
AX-2026-043448	BCH	BCH-2603-G4350	Janoshik	2026-Q3	98.55	4.69	106.9	Buyer-sourced	1	MARGINAL
AX-2026-043318	CPC	CPC-2602-W1610	VendorInvestigate	2026-Q3	98.47	3.12	104.1	Buyer-sourced	1	MARGINAL

Other recent TFC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042265	Humanin (HNG)	TFC-2605-U1300	PeptideMeter	2026-Q3	99.52	6.31	—	Buyer-sourced	0	PASS
AX-2026-042222	SS-31 (Elamipretide)	TFC-2607-R9099	VendorInvestigate	2026-Q3	99.46	5.41	102.6	Buyer-sourced	0	PASS
AX-2026-042236	Humanin (HNG)	TFC-2608-S9940	Nordanalyt	2026-Q3	98.64	1.80	—	Buyer-sourced	0	PASS
AX-2026-042282	Retatrutide	TFC-2608-J1156	Janoshik	2026-Q3	98.54	4.27	—	Buyer-sourced	0	PASS
AX-2026-042226	SS-31 (Elamipretide)	TFC-2607-R9099	Janoshik	2026-Q3	99.62	5.47	—	Buyer-sourced	0	PASS
AX-2026-042217	Semaglutide	TFC-2604-X9037	PeptideMeter	2026-Q3	98.95	4.61	96.9	Buyer-sourced	0	PASS
AX-2026-042339	Sermorelin	TFC-2605-Y2176	Kestrel	2026-Q3	99.93	4.14	—	Supplier-supplied	1	FAIL
AX-2026-042214	Semaglutide	TFC-2604-X9037	Kestrel	2026-Q3	99.87	4.66	103.1	Laboratory-retained	0	PASS