AssayIndex

AX-2025-021169

BPC-157 · 10 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2412-Y6192

MARGINALIDENTITY CONSISTENT
Report ID
AX-2025-021169
Compound
BPC-157
Compound class
Tissue-repair and immunomodulatory peptides
Supplier
WXT — WuXi TIDES (WuXi AppTec Testing Division)
Batch / lot
WXT-2412-Y6192
Declared label claim
10mg
Laboratory
VendorInvestigate
Assay date
27 Jan 2025
Submitted
06 Feb 2025
Quarter
2025-Q1
Submitter
s.haddad
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 nm99.09% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.91% area≤ 2.0PASS
Largest single impurityRP-HPLC — BPC-157 arginine-salt artefact0.53% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula1418.7093DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)1418.7168DaNOT TESTED
Mass accuracyobserved vs theoretical+5.3ppm± 15PASS
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate7.44%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography8.53%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.99%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 calibration6.092.5 – 8.0PASS
Retention time (observed)RP-HPLC, 32 min gradient10.26min10.21 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.940.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²85,129≥ 20,000PASS
Resolution to nearest impurityvs [D-Val]-diastereomer1.04no 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.

0336367251008813451 BPC-15710.26 min · 99.09 % 9.67 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, 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 85,129, and skew follows the reported asymmetry factor of 0.94. 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 0.53 % impurity against a 99.09 % 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 peak10.264,816,08199.09
2BPC-157 arginine-salt artefact9.6725,7600.530.000
3des-Gly truncate (−57 Da)9.9012,1510.25-57.021
4[D-Val]-diastereomer10.114,3740.090.000
5pyroglutamate cyclisation (−17 Da)10.599720.02-17.027
6truncated (1-12)9.249720.02-285.132
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+710.37 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 1418.7168 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+473.9104473.91290.00257.6
2+710.3619710.36570.003856.4
1+1419.71661419.72410.0075100.0
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.

FigureSupplier COAThis reportIndex note
Purity (% area)99.9099.09divergence +0.36 pp vs batch median
Total impurities (% area)not stated0.91
Largest single impurity (% area)not stated0.53
Water (%)not stated7.44
Counter-ion (%)4.28.53
Peptide content (%w/w)91.7not determined
Endotoxin (EU/mg)0.47not determined
Method stated on certificateYEScolumn, 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 → third-party forwarder (2 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date
27 Jan 2025
Submitted to the index
06 Feb 2025
Laboratory
VendorInvestigate, Riga, Latvia
Method basis
32 min gradient · high-resolution MS
Verification status
IDENTITY CONSISTENT
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 WXT-2412-Y6192 n=13

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-021163WXT-2412-Y6192Medutest2025-Q199.377.83Supplier-supplied3MARGINAL
AX-2025-021164WXT-2412-Y6192PeptideMeter2025-Q199.328.57Supplier-supplied3MARGINAL
AX-2025-021165WXT-2412-Y6192Nordanalyt2025-Q199.937.9995.9Supplier-supplied2MARGINAL
AX-2025-021166WXT-2412-Y6192Medutest2025-Q199.548.1689.0Supplier-supplied3MARGINAL
AX-2025-021167WXT-2412-Y6192PeptideMeter2025-Q199.877.1389.6Supplier-supplied4MARGINAL
AX-2025-021168WXT-2412-Y6192Janoshik2025-Q199.327.6590.1Supplier-supplied3MARGINAL
AX-2025-021170WXT-2412-Y6192Kestrel2025-Q199.938.04Supplier-supplied2MARGINAL
AX-2025-021171WXT-2412-Y6192PeptideMeter2025-Q198.567.97104.8Buyer-sourced2MARGINAL
AX-2025-021172WXT-2412-Y6192Janoshik2025-Q199.587.27Supplier-supplied2MARGINAL
AX-2025-021173WXT-2412-Y6192Medutest2025-Q199.937.8199.6Supplier-supplied2MARGINAL
AX-2025-021174WXT-2412-Y6192PeptideMeter2025-Q199.928.05Supplier-supplied2MARGINAL
AX-2025-021175WXT-2412-Y6192Janoshik2025-Q199.387.3190.2Laboratory-retained3MARGINAL
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 WXT records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043488PramlintideWXT-2603-D6052Janoshik2026-Q397.874.37Supplier-supplied1MARGINAL
AX-2026-043406SemaglutideWXT-2604-C4728Janoshik2026-Q397.244.65Supplier-supplied1MARGINAL
AX-2026-043421SermorelinWXT-2608-P4867Janoshik2026-Q398.153.09Supplier-supplied0PASS
AX-2026-043420SermorelinWXT-2608-P4867Medutest2026-Q398.623.0796.4Supplier-supplied0PASS
AX-2026-043423SermorelinWXT-2608-P4867Janoshik2026-Q398.283.8698.5Buyer-sourced0PASS
AX-2026-043401SemaglutideWXT-2604-C4728Medutest2026-Q397.704.7891.5Supplier-supplied1MARGINAL
AX-2026-043400SemaglutideWXT-2604-C4728Nordanalyt2026-Q396.864.11106.4Laboratory-retained1FAIL
AX-2026-043422SermorelinWXT-2608-P4867Medutest2026-Q398.353.59Supplier-supplied1MARGINAL