AssayIndex

AX-2026-043639

BPC-157 · 5 mg declared · PolyPeptide Group (Hangzhou) Co., Ltd. · lot PPG-2511-C7828

PASSVERIFIED
Report ID
AX-2026-043639
Compound
BPC-157
Compound class
Tissue-repair and immunomodulatory peptides
Supplier
PPG — PolyPeptide Group (Hangzhou) Co., Ltd.
Batch / lot
PPG-2511-C7828
Declared label claim
5mg
Laboratory
Janoshik Analytical
Assay date
12 Jan 2026
Submitted
30 Jan 2026
Quarter
2026-Q1
Submitter
a.mensah
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 nm99.65% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.35% area≤ 2.0PASS
Largest single impurityRP-HPLC — pyroglutamate cyclisation (−17 Da)0.20% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula1418.7093DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)1418.7087DaNOT TESTED
Mass accuracyobserved vs theoretical-0.4ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance86.56%w/wNOT TESTED
Target-compound contenttotal peptide content × purity86.26%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen5.60mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content4.831mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim96.6%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.45%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography7.02%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.97%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, partial shrinkage from vial wallwhite 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 calibration6.112.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient9.75min9.62 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.360.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²73,708≥ 20,000PASS
Resolution to nearest impurityvs [D-Val]-diastereomer0.95no 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.

027225444816610888 BPC-1579.75 min · 99.65 % 10.06 same trace · ×200 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 73,708, and skew follows the reported asymmetry factor of 1.36. 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 0.20 % impurity against a 99.65 % 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 peak9.754,843,29999.65
2pyroglutamate cyclisation (−17 Da)10.069,7210.20-17.027
3[D-Val]-diastereomer9.614,8600.100.000
4acetylated N-terminus (+42 Da)10.231,4580.03+42.011
5BPC-157 arginine-salt artefact9.209720.020.000
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, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 1418.7087 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+473.9104473.9102-0.00028.7
2+710.3619710.3616-0.000350.8
1+1419.71661419.7160-0.0006100.0
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 Fischer5.45
Counter-ion (acetate)ion chromatography7.02
Residual solvent + inorganic residueestimated0.97
Total peptide contentby difference86.56
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)99.9099.65divergence +0.07 pp vs batch median
Total impurities (% area)0.100.35
Largest single impurity (% area)not stated0.20
Water (%)3.15.45
Counter-ion (%)2.47.02
Peptide content (%w/w)93.986.56
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 (ambient, 12 d) → laboratory (hand-carried, 7 d) → assay.
Assay date
12 Jan 2026
Submitted to the index
30 Jan 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
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.

baseline_noise
Baseline on this trace is flat enough that the reporting threshold is doing real work rather than hiding peaks in noise. That is a precondition for believing 99.65 % and it is not always met.
racemisation_ala
Epimerisation during activation produces a diastereomer that is mass-identical and only chromatographically separable. At this gradient length the separation exists, and 99.65 % is net of it.
Single records do not establish trends. Where this supplier's quarterly medians are stable across four quarters, a result like this reads as the process rather than the draw — and the timeline page is where to check that.
Section 7

Related records

Same batch — lot PPG-2511-C7828 n=14

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043638PPG-2511-C7828VendorInvestigate2026-Q199.594.38Buyer-sourced0PASS
AX-2026-043640PPG-2511-C7828Kestrel2026-Q199.935.2190.4Buyer-sourced0PASS
AX-2026-043641PPG-2511-C7828VendorInvestigate2026-Q199.475.4794.4Buyer-sourced0PASS
AX-2026-043642PPG-2511-C7828Janoshik2026-Q199.735.3899.7Buyer-sourced0PASS
AX-2026-043643PPG-2511-C7828Medutest2026-Q199.935.3394.0Supplier-supplied0PASS
AX-2026-043644PPG-2511-C7828Medutest2026-Q199.934.90Buyer-sourced0PASS
AX-2026-043645PPG-2511-C7828PeptideMeter2026-Q199.935.4797.4Buyer-sourced0PASS
AX-2026-043646PPG-2511-C7828PeptideMeter2026-Q199.935.25Buyer-sourced0PASS
AX-2026-043647PPG-2511-C7828Medutest2026-Q199.555.1695.7Buyer-sourced0PASS
AX-2026-043648PPG-2511-C7828Janoshik2026-Q199.935.04Buyer-sourced0PASS
AX-2026-043649PPG-2511-C7828Janoshik2026-Q199.575.27Buyer-sourced0PASS
AX-2026-043650PPG-2511-C7828Janoshik2026-Q199.645.0788.9Buyer-sourced1MARGINAL
AX-2026-043651PPG-2511-C7828PeptideMeter2026-Q199.935.29Buyer-sourced0PASS
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 PPG records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043598TesamorelinPPG-2608-A6835Kestrel2026-Q398.912.56100.3Buyer-sourced1FAIL
AX-2026-043597TesamorelinPPG-2608-A6835Janoshik2026-Q398.541.15Buyer-sourced0PASS
AX-2026-043596TesamorelinPPG-2608-A6835PeptideMeter2026-Q398.741.83105.1Buyer-sourced1MARGINAL
AX-2026-043605RetatrutidePPG-2604-X7060Janoshik2026-Q298.174.2999.7Buyer-sourced0PASS
AX-2026-043601RetatrutidePPG-2604-X7060Janoshik2026-Q298.283.9695.3Buyer-sourced0PASS
AX-2026-043668AOD-9604PPG-2602-W8018PeptideMeter2026-Q299.473.06Buyer-sourced0PASS
AX-2026-043670AOD-9604PPG-2602-W8018PeptideMeter2026-Q299.562.71104.5Buyer-sourced0PASS
AX-2026-043630CJC-1295 (no DAC)PPG-2512-D7211Janoshik2026-Q299.665.1192.5Buyer-sourced0PASS