AssayIndex

AX-2026-043449

BPC-157 · 5 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2603-G4350

MARGINALIDENTITY CONSISTENT
Report ID
AX-2026-043449
Compound
BPC-157
Compound class
Tissue-repair and immunomodulatory peptides
Supplier
BCH — Bachem Holding (Suzhou) Co., Ltd.
Batch / lot
BCH-2603-G4350
Declared label claim
5mg
Laboratory
Kestrel Bioanalytical
Assay date
15 Aug 2026
Submitted
07 Sep 2026
Quarter
2026-Q3
Submitter
tu.kaufmann
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, 15 min gradient, 214 nm99.74% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.26% area≤ 2.0PASS
Largest single impurityRP-HPLC — BPC-157 arginine-salt artefact0.12% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula1418.7093DaNOT TESTED
Identity — observed monoisotopic massLC-MS, unit resolution (single quadrupole)1418.7102DaNOT TESTED
Mass accuracyobserved vs theoretical+0.6ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance89.37%w/wNOT TESTED
Target-compound contenttotal peptide content × purity89.14%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen5.12mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content4.564mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim91.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.92%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography4.99%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.72%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 calibration5.362.5 – 8.0PASS
Retention time (observed)RP-HPLC, 15 min gradient5.16min5.19 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.230.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²69,790≥ 20,000PASS
Resolution to nearest impurityvs des-Gly truncate (−57 Da)2.12no 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.

05301106031590421205 BPC-1575.16 min · 99.74 % 4.88 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 048121620 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 15 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 69,790, and skew follows the reported asymmetry factor of 1.23. 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 0.12 % impurity against a 99.74 % 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 peak5.164,847,67399.74
2BPC-157 arginine-salt artefact4.885,8320.120.000
3acetylated N-terminus (+42 Da)5.404,3740.09+42.011
4truncated (1-12)4.681,4580.03-285.132
5des-Gly truncate (−57 Da)4.999720.02-57.021
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 1418.7102 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+473.9104473.91070.00038.0
2+710.3619710.36240.000551.1
1+1419.71661419.71750.0009100.0
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 Fischer4.92
Counter-ion (acetate)ion chromatography4.99
Residual solvent + inorganic residueestimated0.72
Total peptide contentby difference89.37
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)98.599.74divergence -0.09 pp vs batch median
Total impurities (% area)1.500.26
Largest single impurity (% area)not stated0.12
Water (%)not stated4.92
Counter-ion (%)3.54.99
Peptide content (%w/w)92.489.37
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, 12 d) → assay. Submitter did not handle the vial.
Assay date
15 Aug 2026
Submitted to the index
07 Sep 2026
Laboratory
Kestrel Bioanalytical, Melbourne, Australia
Method basis
15 min gradient · unit-resolution MS
Verification status
IDENTITY CONSISTENT
Section 6

Annotations 5

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.

peak_integrator
99.74 % on BPC-157 sits at the top of what this index sees. Read it with the method: Kestrel ran a 15 min gradient here, and the compound fingerprint names a mass-identical species that a shorter run folds into the main peak. On this gradient the figure is well founded.
des_gly
At 99.74 % the deletion-sequence family is at or below the reporting threshold. On a sequence with a hindered coupling that is a statement about coupling efficiency, and a good one.
lambda_214
At 214 nm the amide bond dominates the response, so a peptide impurity is seen roughly in proportion to its size. 99.74 % on this detection is the conservative reading; a 280 nm trace would flatter it.
scale_up_delta
Purity usually falls between gram and kilogram scale. A figure of 99.74 % on a commercial lot rather than a laboratory batch is the more informative version of this result.
dihexa_lipophil
Adding a note that I have seen this pattern before and had nothing to add at the time.
Section 7

Related records

Same batch — lot BCH-2603-G4350 n=12

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043439BCH-2603-G4350PeptideMeter2026-Q399.034.26105.0Supplier-supplied2MARGINAL
AX-2026-043440BCH-2603-G4350VendorInvestigate2026-Q398.614.11Buyer-sourced1MARGINAL
AX-2026-043441BCH-2603-G4350Janoshik2026-Q398.434.73103.7Buyer-sourced1MARGINAL
AX-2026-043442BCH-2603-G4350Janoshik2026-Q398.654.78Buyer-sourced1MARGINAL
AX-2026-043443BCH-2603-G4350Janoshik2026-Q399.364.85Supplier-supplied2MARGINAL
AX-2026-043444BCH-2603-G4350Medutest2026-Q398.075.05104.6Buyer-sourced1MARGINAL
AX-2026-043445BCH-2603-G4350Nordanalyt2026-Q398.424.8793.6Buyer-sourced1MARGINAL
AX-2026-043446BCH-2603-G4350VendorInvestigate2026-Q398.714.80Buyer-sourced1MARGINAL
AX-2026-043447BCH-2603-G4350Janoshik2026-Q398.564.33Buyer-sourced1MARGINAL
AX-2026-043448BCH-2603-G4350Janoshik2026-Q398.554.69106.9Buyer-sourced1MARGINAL
AX-2026-043450BCH-2603-G4350PeptideMeter2026-Q398.304.0691.0Buyer-sourced1MARGINAL
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-2026-043448BCHBCH-2603-G4350Janoshik2026-Q398.554.69106.9Buyer-sourced1MARGINAL
AX-2026-043318CPCCPC-2602-W1610VendorInvestigate2026-Q398.473.12104.1Buyer-sourced1MARGINAL
AX-2026-043446BCHBCH-2603-G4350VendorInvestigate2026-Q398.714.80Buyer-sourced1MARGINAL
Other recent BCH records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043445BPC-157BCH-2603-G4350Nordanalyt2026-Q398.424.8793.6Buyer-sourced1MARGINAL
AX-2026-043440BPC-157BCH-2603-G4350VendorInvestigate2026-Q398.614.11Buyer-sourced1MARGINAL
AX-2026-043442BPC-157BCH-2603-G4350Janoshik2026-Q398.654.78Buyer-sourced1MARGINAL
AX-2026-043471CJC-1295 with DACBCH-2607-H5235Janoshik2026-Q397.465.48Buyer-sourced1FAIL
AX-2026-043477CJC-1295 with DACBCH-2607-H5235VendorInvestigate2026-Q397.625.3299.6Buyer-sourced1MARGINAL
AX-2026-043448BPC-157BCH-2603-G4350Janoshik2026-Q398.554.69106.9Buyer-sourced1MARGINAL
AX-2026-043470CJC-1295 with DACBCH-2607-H5235Janoshik2026-Q397.766.1199.3Supplier-supplied1MARGINAL
AX-2026-043478CJC-1295 with DACBCH-2607-H5235PeptideMeter2026-Q397.635.4290.1Buyer-sourced1MARGINAL