AX-2025-019164 · BPC-157 · SinoPep lot SNP-2502-N4153

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	99.93	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.07	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — pyroglutamate cyclisation (−17 Da)	0.05	% 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)	1418.7145	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+3.7	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	86.56	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	86.50	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.16	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.463	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	89.3	%	90.0 – 110.0	FAIL
Water content	Karl Fischer, coulometric, duplicate	4.54	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	8.53	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.37	%	—	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 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	4.80	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	11.05	min	11.10 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.93	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	61,632	—	≥ 20,000	PASS
Resolution to nearest impurity	vs pyroglutamate cyclisation (−17 Da)	1.98	—	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 61,632, and skew follows the reported asymmetry factor of 0.93. 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 0.05 % impurity against a 99.93 % 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	11.05	4,856,908	99.93	—
2	pyroglutamate cyclisation (−17 Da)	11.41	2,430	0.05	-17.027
3	des-Gly truncate (−57 Da)	10.65	972	0.02	-57.021
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 1418.7145 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	473.9121	0.0017	7.9
2+	710.3619	710.3645	0.0026	54.6
1+	1419.7166	1419.7218	0.0052	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.

Component	Determination	%w/w of cake
Water	Karl Fischer	4.54
Counter-ion (acetate)	ion chromatography	8.53
Residual solvent + inorganic residue	estimated	0.37
Total peptide content	by difference	86.56
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)	99.28	99.93	divergence -0.49 pp vs batch median
Total impurities (% area)	0.72	0.07
Largest single impurity (% area)	0.30	0.05
Water (%)	4.1	4.54
Counter-ion (%)	not stated	8.53
Peptide content (%w/w)	91.1	86.56
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: Retail purchase → submitter (2–8 °C, 2 d) → laboratory (courier, ambient, 7 d) → assay.
Assay date: 27 Aug 2025
Submitted to the index: 29 Aug 2025
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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 3

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.

fill_homogeneity29 Aug 2025

A high figure on one vial is a statement about one vial. The within-lot spread on the batch rollup is what tells you whether the bulk was well mixed, and it is the rarer and more useful number.

quad_unit29 Aug 2025

The index grades identity by instrument class, not by the ppm figure alone: "confirmed" where the determination was made at high resolution, "consistent with" where it was not. The status block above says which applies to this record, and it is worth reading before the number.

lot_traceability29 Aug 2025

Lot SNP-2502-N4153 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.

Section 7

Related records

Same batch — lot SNP-2502-N4153 n=6

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019162	SNP-2502-N4153	Medutest	2025-Q3	99.58	5.29	—	Buyer-sourced	0	PASS
AX-2025-019163	SNP-2502-N4153	VendorInvestigate	2025-Q3	99.93	4.45	—	Buyer-sourced	0	PASS
AX-2025-019165	SNP-2502-N4153	Medutest	2025-Q3	99.84	4.98	103.6	Buyer-sourced	0	PASS
AX-2025-019166	SNP-2502-N4153	VendorInvestigate	2025-Q3	99.56	5.25	—	Buyer-sourced	0	PASS
AX-2025-019167	SNP-2502-N4153	Medutest	2025-Q3	99.69	4.35	106.0	Buyer-sourced	1	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-2026-043319	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 SinoPep records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041867	CJC-1295 with DAC	SNP-2607-C3886	Janoshik	2026-Q3	99.24	5.12	—	Laboratory-retained	1	FAIL
AX-2026-041913	Ipamorelin	SNP-2606-L4478	PeptideMeter	2026-Q3	98.88	5.28	—	Buyer-sourced	0	FAIL
AX-2026-041914	Ipamorelin	SNP-2606-L4478	Janoshik	2026-Q3	99.14	5.49	—	Buyer-sourced	0	PASS
AX-2026-041909	Ipamorelin	SNP-2606-L4478	PeptideMeter	2026-Q3	99.00	5.48	89.5	Buyer-sourced	1	MARGINAL
AX-2026-041895	Ipamorelin	SNP-2602-B3833	Janoshik	2026-Q3	99.93	4.72	105.9	Buyer-sourced	1	MARGINAL
AX-2026-041930	IGF-1 LR3	SNP-2606-D4620	Medutest	2026-Q3	98.54	5.37	93.8	Buyer-sourced	0	PASS
AX-2026-041898	Ipamorelin	SNP-2602-B3833	Nordanalyt	2026-Q3	99.93	4.54	96.0	Buyer-sourced	1	MARGINAL
AX-2026-041931	IGF-1 LR3	SNP-2606-D4620	PeptideMeter	2026-Q3	97.93	5.19	93.4	Buyer-sourced	0	PASS