AssayIndex

AX-2026-043684

BPC-157 · 5 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2603-L7768

FAILPURITY ONLY
Report ID
AX-2026-043684
Compound
BPC-157
Compound class
Tissue-repair and immunomodulatory peptides
Supplier
BCH — Bachem Holding (Suzhou) Co., Ltd.
Batch / lot
BCH-2603-L7768
Declared label claim
5mg
Laboratory
PeptideMeter
Assay date
25 Jul 2026
Submitted
01 Aug 2026
Quarter
2026-Q3
Submitter
ni.zielinski
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, 28 min gradient, 214 nm97.83% area≥ 98.0FAIL
Total impuritiesRP-HPLC, sum of reported peaks2.17% area≤ 2.0FAIL
Largest single impurityRP-HPLC — truncated (1-12)0.90% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance86.64%w/wNOT TESTED
Target-compound contenttotal peptide content × purity84.76%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen5.98mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content5.069mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim101.4%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.01%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography7.49%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.86%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 cake, partially collapsedwhite to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.012.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient9.09min9.03 ± 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)²97,259≥ 20,000PASS
Resolution to nearest impurityvs [D-Val]-diastereomer1.09no 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.

0409081791226916359 BPC-1579.09 min · 97.83 % 8.19 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 051015202530 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 28 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 97,259, 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 0.90 % impurity against a 97.83 % 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 peak9.094,754,84197.83
2truncated (1-12)8.1943,7430.90-285.132
3acetylated N-terminus (+42 Da)9.5434,9940.72+42.011
4pyroglutamate cyclisation (−17 Da)9.3814,5810.30-17.027
5[D-Val]-diastereomer8.965,3460.110.000
6BPC-157 arginine-salt artefact8.583,4020.070.000
7des-Gly truncate (−57 Da)8.773,4020.07-57.021
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 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 Fischer5.01
Counter-ion (acetate)ion chromatography7.49
Residual solvent + inorganic residueestimated0.86
Total peptide contentby difference86.64
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)97.7997.83divergence +0.02 pp vs batch median
Total impurities (% area)2.212.17
Largest single impurity (% area)1.370.90
Water (%)not stated5.01
Counter-ion (%)6.27.49
Peptide content (%w/w)89.786.64
Endotoxin (EU/mg)not statednot 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 → submitter (2–8 °C, 13 d) → laboratory (courier, ambient, 12 d) → assay.
Assay date
25 Jul 2026
Submitted to the index
01 Aug 2026
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 min gradient · high-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.

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.
multiple_compare
Sixty-six compounds and twenty suppliers is a lot of cells. Some records will sit below specification by chance alone, and a single one is not a supplier finding. The per-compound table on the scorecard is the correct denominator.
Section 7

Related records

Same batch — lot BCH-2603-L7768 n=13

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043685BCH-2603-L7768PeptideMeter2026-Q397.575.14Buyer-sourced0FAIL
AX-2026-043686BCH-2603-L7768VendorInvestigate2026-Q397.645.27Buyer-sourced0FAIL
AX-2026-043687BCH-2603-L7768Medutest2026-Q398.195.05103.6Buyer-sourced0PASS
AX-2026-043688BCH-2603-L7768Janoshik2026-Q397.945.56Buyer-sourced0FAIL
AX-2026-043689BCH-2603-L7768Medutest2026-Q397.775.06Buyer-sourced1FAIL
AX-2026-043690BCH-2603-L7768PeptideMeter2026-Q397.295.10Buyer-sourced0FAIL
AX-2026-043691BCH-2603-L7768Janoshik2026-Q398.665.12Supplier-supplied1MARGINAL
AX-2026-043692BCH-2603-L7768VendorInvestigate2026-Q397.605.61Buyer-sourced0FAIL
AX-2026-043693BCH-2603-L7768PeptideMeter2026-Q397.825.2194.9Buyer-sourced0FAIL
AX-2026-043694BCH-2603-L7768Kestrel2026-Q397.605.21Buyer-sourced0FAIL
AX-2026-043695BCH-2603-L7768Janoshik2026-Q397.615.42Buyer-sourced0FAIL
AX-2026-043696BCH-2603-L7768Janoshik2026-Q397.855.28Buyer-sourced0FAIL
Other recent BPC-157 records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043691BCHBCH-2603-L7768Janoshik2026-Q398.665.12Supplier-supplied1MARGINAL
AX-2026-043493CPCCPC-2602-W3201Janoshik2026-Q398.762.27Buyer-sourced2FAIL
AX-2026-041387WWBWWB-2606-H3906Janoshik2026-Q399.334.64Laboratory-retained0PASS
AX-2026-043693BCHBCH-2603-L7768PeptideMeter2026-Q397.825.2194.9Buyer-sourced0FAIL
AX-2026-043686BCHBCH-2603-L7768VendorInvestigate2026-Q397.645.27Buyer-sourced0FAIL
AX-2026-043695BCHBCH-2603-L7768Janoshik2026-Q397.615.42Buyer-sourced0FAIL
AX-2026-043487CPCCPC-2602-W3201VendorInvestigate2026-Q399.072.7697.0Laboratory-retained1MARGINAL
AX-2026-041385WWBWWB-2606-H3906Medutest2026-Q399.294.43Buyer-sourced0PASS
Other recent BCH records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043691BPC-157BCH-2603-L7768Janoshik2026-Q398.665.12Supplier-supplied1MARGINAL
AX-2026-043693BPC-157BCH-2603-L7768PeptideMeter2026-Q397.825.2194.9Buyer-sourced0FAIL
AX-2026-043686BPC-157BCH-2603-L7768VendorInvestigate2026-Q397.645.27Buyer-sourced0FAIL
AX-2026-043695BPC-157BCH-2603-L7768Janoshik2026-Q397.615.42Buyer-sourced0FAIL
AX-2026-043726N-Acetyl Semax AmideBCH-2602-E8475Janoshik2026-Q397.899.67104.2Buyer-sourced0FAIL
AX-2026-043688BPC-157BCH-2603-L7768Janoshik2026-Q397.945.56Buyer-sourced0FAIL
AX-2026-043658BPC-157BCH-2603-G6644Janoshik2026-Q398.454.37101.8Supplier-supplied0PASS
AX-2026-043692BPC-157BCH-2603-L7768VendorInvestigate2026-Q397.605.61Buyer-sourced0FAIL