AssayIndex

AX-2026-043444

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

MARGINALPURITY ONLY
Report ID
AX-2026-043444
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
Medutest
Assay date
17 Jul 2026
Submitted
21 Jul 2026
Quarter
2026-Q3
Submitter
sec_monomer
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 nm98.07% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks1.93% area≤ 2.0PASS
Largest single impurityRP-HPLC — acetylated N-terminus (+42 Da)1.03% area≤ 1.00FAIL
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance88.86%w/wNOT TESTED
Target-compound contenttotal peptide content × purity87.15%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen6.00mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content5.229mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim104.6%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.05%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography5.43%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.66%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 procedureVisible particulates, did not clearclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.282.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient8.20min8.14 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.900.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²55,567≥ 20,000PASS
Resolution to nearest impurityvs [D-Val]-diastereomer0.82no 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.

0343568701030613741 BPC-1578.20 min · 98.07 % 8.60 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 55,567, and skew follows the reported asymmetry factor of 0.90. 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 1.03 % impurity against a 98.07 % 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 peak8.204,766,50698.07
2acetylated N-terminus (+42 Da)8.6050,0611.03+42.011
3pyroglutamate cyclisation (−17 Da)8.4619,9270.41-17.027
4des-Gly truncate (−57 Da)7.9215,0670.31-57.021
5[D-Val]-diastereomer8.085,8320.120.000
6BPC-157 arginine-salt artefact7.741,4580.030.000
7truncated (1-12)7.401,4580.03-285.132
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 Fischer5.05
Counter-ion (acetate)ion chromatography5.43
Residual solvent + inorganic residueestimated0.66
Total peptide contentby difference88.86
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)98.598.07divergence -0.09 pp vs batch median
Total impurities (% area)1.501.93
Largest single impurity (% area)not stated1.03
Water (%)not stated5.05
Counter-ion (%)3.55.43
Peptide content (%w/w)92.488.86
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
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Retail purchase → submitter (2–8 °C, 23 d) → laboratory (courier, ambient, 2 d) → assay.
Assay date
17 Jul 2026
Submitted to the index
21 Jul 2026
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-resolution MS
Verification status
PURITY ONLY
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.

schema_v2
The dataset records the declared purity exactly as printed, including its precision. Anyone testing digit preference over the CSV is testing the certificates rather than the index's handling of them.
peak_integrator
Two laboratories with different gradients will resolve a close pair differently and report two honest, different purities. Neither is wrong and the difference is not a disagreement about the material.
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-2026-043445BCH-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