AssayIndex

AX-2025-020464

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

MARGINALVERIFIED
Report ID
AX-2025-020464
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
Janoshik Analytical
Assay date
18 Nov 2025
Submitted
04 Dec 2025
Quarter
2025-Q4
Submitter
m.lokken
Sample provenance
Supplier-supplied
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, 30 min gradient, 214 nm99.06% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.94% area≤ 2.0PASS
Largest single impurityRP-HPLC — [D-Val]-diastereomer0.68% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula1418.7093Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)1418.7050Da—NOT TESTED
Mass accuracyobserved vs theoretical-3.0ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance86.09%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity85.28%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen6.15mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content5.245mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim104.9%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.16%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography7.85%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.90%—NOT TESTED
Endotoxinnot ordered on this submissionnot determined—≤ 5.0NOT TESTED
Sterilitynot ordered on this submissionnot determined—no growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundOff-white lyophilised cake, intact—white to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear with a single visible fibre—clear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.31—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient9.44min9.62 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.88—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²72,964—≥ 20,000PASS
Resolution to nearest impurityvs [D-Val]-diastereomer0.98—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.

0345469081036113815 BPC-1579.44 min · 99.06 % 9.30 same trace · ×100 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
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 72,964, and skew follows the reported asymmetry factor of 0.88. 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 0.68 % impurity against a 99.06 % 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 peak9.444,814,62399.06—
2[D-Val]-diastereomer9.3033,0500.680.000
3pyroglutamate cyclisation (−17 Da)9.758,2630.17-17.027
4acetylated N-terminus (+42 Da)9.922,4300.05+42.011
5des-Gly truncate (−57 Da)9.109720.02-57.021
6truncated (1-12)8.489720.02-285.132
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+1419.71[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 1418.7050 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+473.9104473.9089-0.00158.7
2+710.3619710.3598-0.002154.8
1+1419.71661419.7123-0.0043100.0
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 Fischer5.16
Counter-ion (acetate)ion chromatography7.85
Residual solvent + inorganic residueestimated0.90
Total peptide contentby difference86.09
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)98.4899.06divergence +0.15 pp vs batch median
Total impurities (% area)1.520.94
Largest single impurity (% area)1.060.68
Water (%)not stated5.16
Counter-ion (%)6.17.85
Peptide content (%w/w)89.886.09
Endotoxin (EU/mg)not statednot determined
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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 9 d) → assay. Submitter did not handle the vial.
Assay date
18 Nov 2025
Submitted to the index
04 Dec 2025
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 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-2025-020465KP-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-2025-020473KP-2511-M5346VendorInvestigate2025-Q497.814.56105.2Buyer-sourced2FAIL
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