AssayIndex

AX-2025-020473

BPC-157 · 5 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2511-M5346

FAILVERIFIED
Report ID
AX-2025-020473
Compound
BPC-157
Compound class
Tissue-repair and immunomodulatory peptides
Supplier
KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot
KP-2511-M5346
Declared label claim
5mg
Laboratory
VendorInvestigate
Assay date
01 Nov 2025
Submitted
06 Nov 2025
Quarter
2025-Q4
Submitter
r.lindholm
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.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 32 min gradient, 214 nm97.81% area≥ 98.0FAIL
Total impuritiesRP-HPLC, sum of reported peaks2.19% area≤ 2.0FAIL
Largest single impurityRP-HPLC — acetylated N-terminus (+42 Da)0.95% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula1418.7093Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)1418.7119Da—NOT TESTED
Mass accuracyobserved vs theoretical+1.8ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance87.83%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity85.91%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen6.12mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content5.258mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim105.2%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.56%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography7.22%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.39%—NOT TESTED
Endotoxinkinetic chromogenic LAL0.52EU/mg≤ 5.0PASS
Sterilitynot ordered on this submissionnot determined—no growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite cake, partial shrinkage from vial wall—white to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureFaint haze, clearing on standing—clear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.95—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 32 min gradient10.10min10.21 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.99—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²47,828—≥ 20,000PASS
Resolution to nearest impurityvs [D-Val]-diastereomer0.79—no index criterionREPORTED
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.

02464492873929856 BPC-15710.10 min · 97.81 % 10.61 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 32 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 47,828, and skew follows the reported asymmetry factor of 0.99. 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 0.95 % impurity against a 97.81 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1BPC-157 — main peak10.104,753,86997.81—
2acetylated N-terminus (+42 Da)10.6146,1730.95+42.011
3BPC-157 arginine-salt artefact9.5139,8550.820.000
4des-Gly truncate (−57 Da)9.7411,6650.24-57.021
5[D-Val]-diastereomer9.956,3180.130.000
6pyroglutamate cyclisation (−17 Da)10.431,4580.03-17.027
7truncated (1-12)9.089720.02-285.132
Closure check — purity + Σ impurities 100.00CLOSES

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.

0255075100350550750950115013501550 [M+1H]1+1419.72[M+2H]2+710.36 m/z Relative abundance (%)
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 1418.7119 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.
ChargeTheoretical m/zObserved m/zΔ m/zRel. abundance (%)
3+473.9104473.91120.00088.2
2+710.3619710.36320.001355.5
1+1419.71661419.71920.0026100.0
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.

ComponentDetermination%w/w of cake
WaterKarl Fischer4.56
Counter-ion (acetate)ion chromatography7.22
Residual solvent + inorganic residueestimated0.39
Total peptide contentby difference87.83
Total100.00 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.

FigureSupplier COAThis reportIndex note
Purity (% area)98.4897.81divergence +0.15 pp vs batch median
Total impurities (% area)1.522.19
Largest single impurity (% area)1.060.95
Water (%)not stated4.56
Counter-ion (%)6.17.22
Peptide content (%w/w)89.887.83
Endotoxin (EU/mg)not stated0.52
Method stated on certificateYES—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 (ambient, 32 d) → laboratory (hand-carried, 11 d) → assay.
Assay date
01 Nov 2025
Submitted to the index
06 Nov 2025
Laboratory
VendorInvestigate, Riga, Latvia
Method basis
32 min gradient · high-resolution MS
Verification status
VERIFIED
Section 6

Annotations

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot KP-2511-M5346 n=17

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020464KP-2511-M5346Janoshik2025-Q499.065.16104.9Supplier-supplied2MARGINAL
AX-2025-020465KP-2511-M5346Janoshik2025-Q498.285.39107.1Supplier-supplied2MARGINAL
AX-2026-043012KP-2511-M5346Nordanalyt2025-Q498.335.04—Supplier-supplied2MARGINAL
AX-2025-020466KP-2511-M5346Janoshik2025-Q498.465.0396.9Supplier-supplied2MARGINAL
AX-2026-043013KP-2511-M5346PeptideMeter2025-Q498.295.10106.4Supplier-supplied2MARGINAL
AX-2025-020467KP-2511-M5346Janoshik2025-Q498.265.30101.5Supplier-supplied2MARGINAL
AX-2025-020468KP-2511-M5346Janoshik2025-Q498.834.66—Supplier-supplied2MARGINAL
AX-2025-020469KP-2511-M5346Janoshik2025-Q498.084.70—Supplier-supplied2MARGINAL
AX-2025-020470KP-2511-M5346Janoshik2025-Q498.735.13—Supplier-supplied2MARGINAL
AX-2025-020471KP-2511-M5346Medutest2025-Q498.545.72103.9Buyer-sourced3FAIL
AX-2025-020472KP-2511-M5346Janoshik2025-Q498.774.73—Supplier-supplied2MARGINAL
AX-2025-020474KP-2511-M5346Nordanalyt2025-Q498.804.70—Supplier-supplied2MARGINAL
AX-2025-020475KP-2511-M5346Janoshik2025-Q498.044.9791.0Buyer-sourced2MARGINAL
AX-2025-020476KP-2511-M5346Janoshik2025-Q498.115.18—Buyer-sourced2MARGINAL
AX-2025-020477KP-2511-M5346Janoshik2025-Q498.665.00—Supplier-supplied2MARGINAL
AX-2025-020478KP-2511-M5346PeptideMeter2025-Q498.055.3395.1Supplier-supplied2MARGINAL

Cross-sections

Other recent BPC-157 records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041387WWBWWB-2606-H3906Janoshik2026-Q398.954.64—Laboratory-retained1MARGINAL
AX-2026-043365CPCCPC-2602-W2646Medutest2026-Q398.562.80—Supplier-supplied1MARGINAL
AX-2026-041385WWBWWB-2606-H3906Medutest2026-Q399.314.31—Supplier-supplied1MARGINAL
AX-2026-043503BCHBCH-2603-G6422Janoshik2026-Q398.464.32—Supplier-supplied1MARGINAL
AX-2026-041390WWBWWB-2606-H3906Medutest2026-Q399.474.8499.3Supplier-supplied1MARGINAL
AX-2026-041386WWBWWB-2606-H3906VendorInvestigate2026-Q399.324.8899.2Buyer-sourced1MARGINAL
AX-2026-041380WWBWWB-2606-H3906PeptideMeter2026-Q399.454.52—Supplier-supplied1MARGINAL
AX-2026-041383WWBWWB-2606-H3906PeptideMeter2026-Q399.174.8491.2Supplier-supplied1MARGINAL
Other recent KP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043029RetatrutideKP-2607-H5219Medutest2026-Q395.455.71—Supplier-supplied2FAIL
AX-2026-043030RetatrutideKP-2607-H5219Kestrel2026-Q395.976.9597.1Supplier-supplied2FAIL
AX-2026-043106TirzepatideKP-2608-D5921PeptideMeter2026-Q398.905.45105.4Supplier-supplied2MARGINAL
AX-2026-043108TirzepatideKP-2608-D5921Janoshik2026-Q399.705.45—Supplier-supplied2MARGINAL
AX-2026-043039RetatrutideKP-2607-H5219Janoshik2026-Q396.145.62—Supplier-supplied2FAIL
AX-2026-043100TirzepatideKP-2608-D5921VendorInvestigate2026-Q398.275.3194.4Buyer-sourced2MARGINAL
AX-2026-043090IpamorelinKP-2606-D5887Janoshik2026-Q398.183.07101.2Laboratory-retained1FAIL
AX-2026-043028RetatrutideKP-2607-H5219Janoshik2026-Q396.526.09—Supplier-supplied2MARGINAL