AssayIndex

AX-2026-043418

BPC-157 · 5 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2602-W3200

FAILIDENTITY CONSISTENT
Report ID
AX-2026-043418
Compound
BPC-157
Compound class
Tissue-repair and immunomodulatory peptides
Supplier
WXT — WuXi TIDES (WuXi AppTec Testing Division)
Batch / lot
WXT-2602-W3200
Declared label claim
5mg
Laboratory
Medutest
Assay date
05 Jun 2026
Submitted
27 Jun 2026
Quarter
2026-Q2
Submitter
f.grimaldi
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, 25 min gradient, 214 nm97.79% area≥ 98.0FAIL
Total impuritiesRP-HPLC, sum of reported peaks2.21% area≤ 2.0FAIL
Largest single impurityRP-HPLC — truncated (1-12)1.01% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula1418.7093DaNOT TESTED
Identity — observed monoisotopic massLC-MS, unit resolution (single quadrupole)1418.7079DaNOT TESTED
Mass accuracyobserved vs theoretical-1.0ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance87.28%w/wNOT TESTED
Target-compound contenttotal peptide content × purity85.35%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen6.29mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content5.369mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim107.4%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.69%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography7.13%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.90%NOT TESTED
Endotoxinkinetic chromogenic LAL1.08EU/mg≤ 5.0PASS
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 dno growthPASS
Appearancevisual, diffuse light, black and white backgroundOff-white lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear with a single visible fibreclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.262.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient8.14min8.14 ± 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)²65,519≥ 20,000PASS
Resolution to nearest impurityvs [D-Val]-diastereomer0.89no 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.

0374774941124114988 BPC-1578.14 min · 97.79 % 7.34 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0481216202428 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 25 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 65,519, 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 1.01 % impurity against a 97.79 % 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 peak8.144,752,89797.79
2truncated (1-12)7.3449,0891.01-285.132
3acetylated N-terminus (+42 Da)8.5431,5920.65+42.011
4des-Gly truncate (−57 Da)7.8615,0670.31-57.021
5[D-Val]-diastereomer8.027,2900.150.000
6pyroglutamate cyclisation (−17 Da)8.402,9160.06-17.027
7BPC-157 arginine-salt artefact7.681,4580.030.000
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, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 1418.7079 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+473.9104473.9099-0.00059.0
2+710.3619710.3612-0.000755.4
1+1419.71661419.7152-0.0014100.0
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 Fischer4.69
Counter-ion (acetate)ion chromatography7.13
Residual solvent + inorganic residueestimated0.90
Total peptide contentby difference87.28
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)97.7697.79divergence -0.08 pp vs batch median
Total impurities (% area)2.242.21
Largest single impurity (% area)1.171.01
Water (%)3.14.69
Counter-ion (%)not stated7.13
Peptide content (%w/w)not stated87.28
Endotoxin (EU/mg)not stated1.08
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
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Retail purchase → submitter (2–8 °C, 21 d) → laboratory (courier, ambient, 5 d) → assay.
Assay date
05 Jun 2026
Submitted to the index
27 Jun 2026
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-resolution MS
Verification status
IDENTITY CONSISTENT
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.

wide_iqr
97.79 % on BPC-157 is below the index specification for the class. The interesting part is the distribution: truncated (1-12) at 1.01 % is doing most of the work, and that species is a synthesis artefact rather than a degradation product. This is a process observation about lot WXT-2602-W3200, not a storage one.
mass_defect
Before assigning truncated (1-12) from retention alone, check the mass defect on the impurity peak. Plausible and implausible assignments separate cleanly and the check costs nothing.
coa_reader
What would resolve this quickly is the batch record rather than the summary certificate — the in-process chromatogram, the fraction cut, and the reporting threshold applied. Every supplier scorecarded here holds one.
Section 7

Related records

Same batch — lot WXT-2602-W3200 n=7

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043416WXT-2602-W3200Janoshik2026-Q297.585.03Buyer-sourced0FAIL
AX-2026-043417WXT-2602-W3200Janoshik2026-Q297.845.24Buyer-sourced0FAIL
AX-2026-043419WXT-2602-W3200Janoshik2026-Q298.005.13103.2Supplier-supplied0PASS
AX-2026-043420WXT-2602-W3200Medutest2026-Q298.034.96107.4Buyer-sourced0PASS
AX-2026-043421WXT-2602-W3200Medutest2026-Q298.644.86Supplier-supplied0PASS
AX-2026-043422WXT-2602-W3200Medutest2026-Q297.454.4993.4Buyer-sourced0FAIL
Other recent BPC-157 records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043319CPCCPC-2602-W1610Medutest2026-Q398.822.88103.5Buyer-sourced2MARGINAL
AX-2026-041766TFSTFS-{CAT}-1156Janoshik2026-Q399.546.34Buyer-sourced1MARGINAL
AX-2026-043445BCHBCH-2603-G4350Nordanalyt2026-Q398.424.8793.6Buyer-sourced1MARGINAL
AX-2026-043440BCHBCH-2603-G4350VendorInvestigate2026-Q398.614.11Buyer-sourced1MARGINAL
AX-2026-043442BCHBCH-2603-G4350Janoshik2026-Q398.654.78Buyer-sourced1MARGINAL
AX-2026-043449BCHBCH-2603-G4350Kestrel2026-Q399.744.9291.3Supplier-supplied2MARGINAL
AX-2026-043448BCHBCH-2603-G4350Janoshik2026-Q398.554.69106.9Buyer-sourced1MARGINAL
AX-2026-043318CPCCPC-2602-W1610VendorInvestigate2026-Q398.473.12104.1Buyer-sourced1MARGINAL
Other recent WXT records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043376SemaglutideWXT-2604-C3248Janoshik2026-Q397.084.22Buyer-sourced1MARGINAL
AX-2026-043429L-Glutathione (reduced)WXT-2605-B3833Nordanalyt2026-Q398.486.5896.9Supplier-supplied1FAIL
AX-2026-043347LeuprolideWXT-2604-K2596PeptideMeter2026-Q399.165.9993.6Buyer-sourced0PASS
AX-2026-043353LeuprolideWXT-2604-K2596Janoshik2026-Q399.194.9095.3Laboratory-retained0PASS
AX-2026-043345LeuprolideWXT-2604-K2596Janoshik2026-Q398.935.28Buyer-sourced0PASS
AX-2026-043424L-Glutathione (reduced)WXT-2605-B3833PeptideMeter2026-Q398.376.86Buyer-sourced0FAIL
AX-2026-043374SemaglutideWXT-2604-C3248Janoshik2026-Q397.003.56Buyer-sourced1MARGINAL
AX-2026-043377SemaglutideWXT-2604-C3248PeptideMeter2026-Q397.204.08Buyer-sourced1MARGINAL