AX-2026-043689 · BPC-157 · BCH lot BCH-2603-L7768

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	97.77	% area	≥ 98.0	FAIL
Total impurities	RP-HPLC, sum of reported peaks	2.23	% area	≤ 2.0	FAIL
Largest single impurity	RP-HPLC — truncated (1-12)	0.90	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	1418.7093	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	1418.6869	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-15.8	ppm	± 15	FAIL
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	5.06	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	6.29	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.52	%	—	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 to pale-yellow 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	5.09	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	8.31	min	8.14 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.00	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	53,478	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Val]-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, 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 53,478, and skew follows the reported asymmetry factor of 1.00. 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 0.90 % impurity against a 97.77 % 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	8.31	4,751,925	97.77	—
2	truncated (1-12)	7.51	43,743	0.90	-285.132
3	des-Gly truncate (−57 Da)	8.03	37,424	0.77	-57.021
4	acetylated N-terminus (+42 Da)	8.71	16,039	0.33	+42.011
5	pyroglutamate cyclisation (−17 Da)	8.57	7,290	0.15	-17.027
6	BPC-157 arginine-salt artefact	7.85	2,430	0.05	0.000
7	[D-Val]-diastereomer	8.19	1,458	0.03	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 1418.7093 Da, computed from C62H98N16O22. 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 1418.6869 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 (%)
3+	473.9104	473.9029	-0.0075	7.6
2+	710.3619	710.3507	-0.0112	54.0
1+	1419.7166	1419.6942	-0.0224	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.

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)	97.79	97.77	divergence +0.02 pp vs batch median
Total impurities (% area)	2.21	2.23
Largest single impurity (% area)	1.37	0.90
Water (%)	not stated	5.06
Counter-ion (%)	6.2	6.29
Peptide content (%w/w)	89.7	not determined
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: Domestic warehouse despatch → submitter (2–8 °C, 27 d) → laboratory (courier, cold pack, 11 d) → assay.
Assay date: 24 Jul 2026
Submitted to the index: 16 Aug 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.
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 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 5

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_budget16 Aug 2026

The gap between 97.77 % and the class specification should be read against an expanded uncertainty of roughly ±0.5 pp. A shortfall inside that band is not a finding; a shortfall well outside it is.

des_gly16 Aug 2026

The record is published in full, including the impurity table that explains it. A number below specification with a named impurity profile beside it is more useful than a number above specification with nothing beside it.

sodium_adduct16 Aug 2026

An unrecognised sodium adduct shifts an apparent monoisotopic mass by about 22 Da, which at this molecular weight is far more than -15.8 ppm. Rule that out first; it is the cheapest check available.

buyer_sourced16 Aug 2026

A retail vial at 97.77 % is worth more evidentially than a selected vial at a higher figure. That is the whole argument for recording provenance at all.

counterion_mol16 Aug 2026

Fair.

Section 7

Related records

Same batch — lot BCH-2603-L7768 n=13

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043684	BCH-2603-L7768	PeptideMeter	2026-Q3	97.83	5.01	101.4	Buyer-sourced	0	FAIL
AX-2026-043685	BCH-2603-L7768	PeptideMeter	2026-Q3	97.57	5.14	—	Buyer-sourced	0	FAIL
AX-2026-043686	BCH-2603-L7768	VendorInvestigate	2026-Q3	97.64	5.27	—	Buyer-sourced	0	FAIL
AX-2026-043687	BCH-2603-L7768	Medutest	2026-Q3	98.19	5.05	103.6	Buyer-sourced	0	PASS
AX-2026-043688	BCH-2603-L7768	Janoshik	2026-Q3	97.94	5.56	—	Buyer-sourced	0	FAIL
AX-2026-043690	BCH-2603-L7768	PeptideMeter	2026-Q3	97.29	5.10	—	Buyer-sourced	0	FAIL
AX-2026-043691	BCH-2603-L7768	Janoshik	2026-Q3	98.66	5.12	—	Supplier-supplied	1	MARGINAL
AX-2026-043692	BCH-2603-L7768	VendorInvestigate	2026-Q3	97.60	5.61	—	Buyer-sourced	0	FAIL
AX-2026-043693	BCH-2603-L7768	PeptideMeter	2026-Q3	97.82	5.21	94.9	Buyer-sourced	0	FAIL
AX-2026-043694	BCH-2603-L7768	Kestrel	2026-Q3	97.60	5.21	—	Buyer-sourced	0	FAIL
AX-2026-043695	BCH-2603-L7768	Janoshik	2026-Q3	97.61	5.42	—	Buyer-sourced	0	FAIL
AX-2026-043696	BCH-2603-L7768	Janoshik	2026-Q3	97.85	5.28	—	Buyer-sourced	0	FAIL

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-2026-043691	BCH	BCH-2603-L7768	Janoshik	2026-Q3	98.66	5.12	—	Supplier-supplied	1	MARGINAL
AX-2026-043493	CPC	CPC-2602-W3201	Janoshik	2026-Q3	98.76	2.27	—	Buyer-sourced	2	FAIL
AX-2026-041387	WWB	WWB-2606-H3906	Janoshik	2026-Q3	99.33	4.64	—	Laboratory-retained	0	PASS
AX-2026-043693	BCH	BCH-2603-L7768	PeptideMeter	2026-Q3	97.82	5.21	94.9	Buyer-sourced	0	FAIL
AX-2026-043686	BCH	BCH-2603-L7768	VendorInvestigate	2026-Q3	97.64	5.27	—	Buyer-sourced	0	FAIL
AX-2026-043695	BCH	BCH-2603-L7768	Janoshik	2026-Q3	97.61	5.42	—	Buyer-sourced	0	FAIL
AX-2026-043487	CPC	CPC-2602-W3201	VendorInvestigate	2026-Q3	99.07	2.76	97.0	Laboratory-retained	1	MARGINAL
AX-2026-041385	WWB	WWB-2606-H3906	Medutest	2026-Q3	99.29	4.43	—	Buyer-sourced	0	PASS

Other recent BCH records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043691	BPC-157	BCH-2603-L7768	Janoshik	2026-Q3	98.66	5.12	—	Supplier-supplied	1	MARGINAL
AX-2026-043693	BPC-157	BCH-2603-L7768	PeptideMeter	2026-Q3	97.82	5.21	94.9	Buyer-sourced	0	FAIL
AX-2026-043686	BPC-157	BCH-2603-L7768	VendorInvestigate	2026-Q3	97.64	5.27	—	Buyer-sourced	0	FAIL
AX-2026-043695	BPC-157	BCH-2603-L7768	Janoshik	2026-Q3	97.61	5.42	—	Buyer-sourced	0	FAIL
AX-2026-043726	N-Acetyl Semax Amide	BCH-2602-E8475	Janoshik	2026-Q3	97.89	9.67	104.2	Buyer-sourced	0	FAIL
AX-2026-043688	BPC-157	BCH-2603-L7768	Janoshik	2026-Q3	97.94	5.56	—	Buyer-sourced	0	FAIL
AX-2026-043658	BPC-157	BCH-2603-G6644	Janoshik	2026-Q3	98.45	4.37	101.8	Supplier-supplied	0	PASS
AX-2026-043692	BPC-157	BCH-2603-L7768	VendorInvestigate	2026-Q3	97.60	5.61	—	Buyer-sourced	0	FAIL