AssayIndex

AX-2025-018512

BPC-157 · 5 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2502-F3190

PASSPURITY ONLY
Report ID
AX-2025-018512
Compound
BPC-157
Compound class
Tissue-repair and immunomodulatory peptides
Supplier
WWB — Wuhan Wansheng Biotechnology Co., Ltd.
Batch / lot
WWB-2502-F3190
Declared label claim
5mg
Laboratory
PeptideMeter
Assay date
14 Mar 2025
Submitted
23 Mar 2025
Quarter
2025-Q1
Submitter
a.lundgren
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, 28 min gradient, 214 nm99.93% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.07% area≤ 2.0PASS
Largest single impurityRP-HPLC — BPC-157 arginine-salt artefact0.04% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance87.54%w/wNOT TESTED
Target-compound contenttotal peptide content × purity87.48%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen5.91mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content5.170mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim103.4%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.33%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography6.13%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/1.00%NOT TESTED
Endotoxinnot ordered on this submissionnot determined≤ 5.0NOT TESTED
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.692.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient8.97min9.03 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.860.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²70,722≥ 20,000PASS
Resolution to nearest impurityvs BPC-157 arginine-salt artefact3.71no 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.

0361072201083014440 BPC-1578.97 min · 99.93 % 8.46 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 051015202530 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 28 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 70,722, and skew follows the reported asymmetry factor of 0.86. 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 0.04 % impurity against a 99.93 % 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 peak8.974,856,90899.93
2BPC-157 arginine-salt artefact8.461,9440.040.000
3truncated (1-12)8.071,4580.03-285.132
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 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 Fischer5.33
Counter-ion (acetate)ion chromatography6.13
Residual solvent + inorganic residueestimated1.00
Total peptide contentby difference87.54
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)99.9099.93divergence -0.03 pp vs batch median
Total impurities (% area)0.100.07
Largest single impurity (% area)not stated0.04
Water (%)3.65.33
Counter-ion (%)8.06.13
Peptide content (%w/w)87.887.54
Endotoxin (EU/mg)not statednot determined
Method stated on certificateNOno method section — the result cannot be reconciled against any other
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, 7 d) → assay. Submitter did not handle the vial.
Assay date
14 Mar 2025
Submitted to the index
23 Mar 2025
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 min gradient · high-resolution MS
Verification status
PURITY ONLY
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 WWB-2502-F3190 n=3

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-018513WWB-2502-F3190Janoshik2025-Q199.935.7695.1Supplier-supplied0PASS
AX-2025-018514WWB-2502-F3190Janoshik2025-Q199.935.0599.7Supplier-supplied0PASS
Other recent BPC-157 records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041387WWBWWB-2606-H3906Janoshik2026-Q398.954.64Laboratory-retained1MARGINAL
AX-2026-043365CPCCPC-2602-W2646Medutest2026-Q398.562.80Supplier-supplied1MARGINAL
AX-2026-041385WWBWWB-2606-H3906Medutest2026-Q399.314.31Supplier-supplied1MARGINAL
AX-2026-043503BCHBCH-2603-G6422Janoshik2026-Q398.464.32Supplier-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-Q399.454.52Supplier-supplied1MARGINAL
AX-2026-041383WWBWWB-2606-H3906PeptideMeter2026-Q399.174.8491.2Supplier-supplied1MARGINAL
Other recent WWB records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041275LiraglutideWWB-2607-X2189Nordanalyt2026-Q399.615.0397.3Supplier-supplied0PASS
AX-2026-041387BPC-157WWB-2606-H3906Janoshik2026-Q398.954.64Laboratory-retained1MARGINAL
AX-2026-041334SemaglutideWWB-2606-N3192Janoshik2026-Q398.835.04Supplier-supplied1MARGINAL
AX-2026-041337SemaglutideWWB-2606-N3192Nordanalyt2026-Q398.964.81Supplier-supplied1MARGINAL
AX-2026-041385BPC-157WWB-2606-H3906Medutest2026-Q399.314.31Supplier-supplied1MARGINAL
AX-2026-041390BPC-157WWB-2606-H3906Medutest2026-Q399.474.8499.3Supplier-supplied1MARGINAL
AX-2026-041386BPC-157WWB-2606-H3906VendorInvestigate2026-Q399.324.8899.2Buyer-sourced1MARGINAL
AX-2026-041335SemaglutideWWB-2606-N3192Janoshik2026-Q399.554.55100.5Supplier-supplied1MARGINAL