AX-2026-043132

BPC-157 · 2 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2601-N6863

MARGINALIDENTITY CONSISTENT

Report ID: AX-2026-043132
Compound: BPC-157
Compound class: Tissue-repair and immunomodulatory peptides
Supplier: SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Batch / lot: SSA-2601-N6863
Declared label claim: 2mg
Laboratory: Janoshik Analytical
Assay date: 07 Apr 2026
Submitted: 18 Apr 2026
Quarter: 2026-Q2
Submitter: n.adeyemi
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, 30 min gradient, 214 nm	98.03	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.97	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — acetylated N-terminus (+42 Da)	0.77	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	1418.7093	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	1418.7065	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-2.0	ppm	± 15	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	4.34	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.93	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.47	%	—	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	5.42	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	9.75	min	9.62 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.16	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	62,010	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Val]-diastereomer	0.87	—	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, 30 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 62,010, and skew follows the reported asymmetry factor of 1.16. 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 0.77 % impurity against a 98.03 % 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	9.75	4,764,562	98.03	—
2	acetylated N-terminus (+42 Da)	10.23	37,424	0.77	+42.011
3	des-Gly truncate (−57 Da)	9.41	36,452	0.75	-57.021
4	truncated (1-12)	8.79	14,095	0.29	-285.132
5	BPC-157 arginine-salt artefact	9.20	5,346	0.11	0.000
6	pyroglutamate cyclisation (−17 Da)	10.06	1,458	0.03	-17.027
7	[D-Val]-diastereomer	9.61	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 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, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 1418.7065 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	473.9094	-0.0010	7.6
2+	710.3619	710.3605	-0.0014	54.1
1+	1419.7166	1419.7138	-0.0028	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)	97.5	98.03	divergence -0.53 pp vs batch median
Total impurities (% area)	not stated	1.97
Largest single impurity (% area)	not stated	0.77
Water (%)	3.6	4.34
Counter-ion (%)	8.3	4.93
Peptide content (%w/w)	87.5	not determined
Endotoxin (EU/mg)	0.47	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: Retail purchase → submitter (−20 °C, 18 d) → laboratory (courier, dry ice, 8 d) → assay.
Assay date: 07 Apr 2026
Submitted to the index: 18 Apr 2026
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

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 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.

diode_array18 Apr 2026

Spectral homogeneity across the main peak would complete this record. Mass confirms what eluted; the spectrum confirms that only one thing did.

uncertainty_budget18 Apr 2026

Expanded uncertainty on a purity figure is about half a point. A declaration rounded to the nearest half point is quantising at roughly the resolution of the measurement, which is defensible practice rather than sloppy practice.

Section 7

Related records

Same batch — lot SSA-2601-N6863 n=15

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043130	SSA-2601-N6863	Janoshik	2026-Q2	97.57	4.69	100.4	Buyer-sourced	1	FAIL
AX-2026-043131	SSA-2601-N6863	Janoshik	2026-Q2	97.75	4.43	100.0	Buyer-sourced	1	FAIL
AX-2026-043133	SSA-2601-N6863	Janoshik	2026-Q2	98.37	4.34	106.6	Supplier-supplied	1	MARGINAL
AX-2026-043134	SSA-2601-N6863	Medutest	2026-Q2	97.89	4.01	—	Buyer-sourced	1	FAIL
AX-2026-043135	SSA-2601-N6863	Nordanalyt	2026-Q2	98.16	4.66	92.8	Buyer-sourced	1	MARGINAL
AX-2026-043136	SSA-2601-N6863	Janoshik	2026-Q2	98.52	4.02	92.4	Buyer-sourced	1	MARGINAL
AX-2026-043137	SSA-2601-N6863	PeptideMeter	2026-Q2	98.17	4.14	—	Buyer-sourced	1	MARGINAL
AX-2026-043138	SSA-2601-N6863	VendorInvestigate	2026-Q2	97.99	4.20	90.1	Buyer-sourced	1	FAIL
AX-2026-043139	SSA-2601-N6863	Janoshik	2026-Q2	97.78	4.67	99.8	Buyer-sourced	1	FAIL
AX-2026-043140	SSA-2601-N6863	PeptideMeter	2026-Q2	97.86	4.85	105.9	Buyer-sourced	1	FAIL
AX-2026-043141	SSA-2601-N6863	Janoshik	2026-Q2	98.06	4.06	94.6	Buyer-sourced	1	MARGINAL
AX-2026-043142	SSA-2601-N6863	Medutest	2026-Q2	98.19	4.83	95.2	Buyer-sourced	1	MARGINAL
AX-2026-043143	SSA-2601-N6863	Janoshik	2026-Q2	97.91	5.02	—	Buyer-sourced	1	FAIL
AX-2026-043144	SSA-2601-N6863	Janoshik	2026-Q2	98.08	4.74	—	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 SSA records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043135	BPC-157	SSA-2601-N6863	Nordanalyt	2026-Q2	98.16	4.66	92.8	Buyer-sourced	1	MARGINAL
AX-2026-043160	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.01	4.02	91.8	Buyer-sourced	0	PASS
AX-2026-043157	GHK-Cu	SSA-2604-V7731	Medutest	2026-Q2	99.19	5.14	—	Supplier-supplied	0	PASS
AX-2026-043141	BPC-157	SSA-2601-N6863	Janoshik	2026-Q2	98.06	4.06	94.6	Buyer-sourced	1	MARGINAL
AX-2026-043154	GHK-Cu	SSA-2604-V7731	PeptideMeter	2026-Q2	97.82	4.82	101.6	Buyer-sourced	0	PASS
AX-2026-043137	BPC-157	SSA-2601-N6863	PeptideMeter	2026-Q2	98.17	4.14	—	Buyer-sourced	1	MARGINAL
AX-2026-043162	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.50	4.36	—	Supplier-supplied	0	PASS
AX-2026-043134	BPC-157	SSA-2601-N6863	Medutest	2026-Q2	97.89	4.01	—	Buyer-sourced	1	FAIL