AssayIndex

AX-2026-043441

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

MARGINALVERIFIED
Report ID
AX-2026-043441
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
Janoshik Analytical
Assay date
07 Jul 2026
Submitted
22 Jul 2026
Quarter
2026-Q3
Submitter
r.nilsen
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, 30 min gradient, 214 nm98.43% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks1.57% area≤ 2.0PASS
Largest single impurityRP-HPLC — BPC-157 arginine-salt artefact1.05% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula1418.7093DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)1418.7042DaNOT TESTED
Mass accuracyobserved vs theoretical-3.6ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance88.54%w/wNOT TESTED
Target-compound contenttotal peptide content × purity87.15%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen5.95mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content5.185mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim103.7%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.73%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography6.49%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.24%NOT TESTED
Endotoxinkinetic chromogenic LAL1.45EU/mg≤ 5.0PASS
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 with a single visible fibreclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.872.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient9.66min9.62 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.880.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²57,933≥ 20,000PASS
Resolution to nearest impurityvs [D-Val]-diastereomer0.85no 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.

029885977896511953 BPC-1579.66 min · 98.43 % 9.11 same trace · ×50 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 57,933, 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 1.05 % impurity against a 98.43 % 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 peak9.664,784,00398.43
2BPC-157 arginine-salt artefact9.1151,0331.050.000
3acetylated N-terminus (+42 Da)10.1415,0670.31+42.011
4truncated (1-12)8.705,3460.11-285.132
5des-Gly truncate (−57 Da)9.322,9160.06-57.021
6[D-Val]-diastereomer9.529720.020.000
7pyroglutamate cyclisation (−17 Da)9.979720.02-17.027
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 1418.7042 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+473.9104473.9087-0.00178.0
2+710.3619710.3594-0.002551.8
1+1419.71661419.7115-0.0051100.0
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 Fischer4.73
Counter-ion (acetate)ion chromatography6.49
Residual solvent + inorganic residueestimated0.24
Total peptide contentby difference88.54
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)98.598.43divergence -0.09 pp vs batch median
Total impurities (% area)1.501.57
Largest single impurity (% area)not stated1.05
Water (%)not stated4.73
Counter-ion (%)3.56.49
Peptide content (%w/w)92.488.54
Endotoxin (EU/mg)not stated1.45
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 (−20 °C, 14 d) → laboratory (courier, dry ice, 9 d) → assay.
Assay date
07 Jul 2026
Submitted to the index
22 Jul 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
Section 6

Annotations 2

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.

coa_template
Two suppliers using the same certificate template usually share a contract laboratory. That is a supply-chain observation and it is more interesting than the rounding itself.
price_per_mg
A retail purchase carries a price, which makes cost per milligram of recovered peptide computable. That is the comparison a buyer actually needs and it exists only for this provenance class.
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-2026-043442BCH-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-2026-043449BCH-2603-G4350Kestrel2026-Q399.744.9291.3Supplier-supplied2MARGINAL
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-2026-043449BCHBCH-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 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-2026-043449BPC-157BCH-2603-G4350Kestrel2026-Q399.744.9291.3Supplier-supplied2MARGINAL
AX-2026-043448BPC-157BCH-2603-G4350Janoshik2026-Q398.554.69106.9Buyer-sourced1MARGINAL
AX-2026-043470CJC-1295 with DACBCH-2607-H5235Janoshik2026-Q397.766.1199.3Supplier-supplied1MARGINAL