AssayIndex

AX-2025-018940

BPC-157 · 2 mg declared · Thermo Fisher Scientific (China) Co., Ltd. · lot TFS-{CAT}-1157

PASSVERIFIED
Report ID
AX-2025-018940
Compound
BPC-157
Compound class
Tissue-repair and immunomodulatory peptides
Supplier
TFS — Thermo Fisher Scientific (China) Co., Ltd.
Batch / lot
TFS-{CAT}-1157
Declared label claim
2mg
Laboratory
Janoshik Analytical
Assay date
06 Dec 2025
Submitted
24 Dec 2025
Quarter
2025-Q4
Submitter
same_trace_twice
Sample provenance
Laboratory-retained
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 nm99.72% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.28% area≤ 2.0PASS
Largest single impurityRP-HPLC — pyroglutamate cyclisation (−17 Da)0.13% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula1418.7093Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)1418.7087Da—NOT TESTED
Mass accuracyobserved vs theoretical-0.4ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance88.28%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity88.03%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen2.09mg2 mg declaredNOT TESTED
Recovered target peptidegross fill × target content1.840mg2 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim92.0%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.28%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography5.92%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.52%—NOT TESTED
Endotoxinkinetic chromogenic LAL0.31EU/mg≤ 5.0PASS
Sterilitynot ordered on this submissionnot determined—no growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite lyophilised cake, intact—white to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.76—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient9.72min9.62 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.91—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²80,370—≥ 20,000PASS
Resolution to nearest impurityvs [D-Val]-diastereomer1.00—no 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.

0352570511057614101 BPC-1579.72 min · 99.72 % 10.03 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 80,370, and skew follows the reported asymmetry factor of 0.91. 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 0.13 % impurity against a 99.72 % 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 peak9.724,846,70199.72—
2pyroglutamate cyclisation (−17 Da)10.036,3180.13-17.027
3[D-Val]-diastereomer9.584,8600.100.000
4des-Gly truncate (−57 Da)9.381,4580.03-57.021
5acetylated N-terminus (+42 Da)10.209720.02+42.011
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+473.9104473.9102-0.00029.5
2+710.3619710.3616-0.000359.7
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 Fischer5.28
Counter-ion (acetate)ion chromatography5.92
Residual solvent + inorganic residueestimated0.52
Total peptide contentby difference88.28
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)99.5299.72divergence -0.28 pp vs batch median
Total impurities (% area)0.480.28
Largest single impurity (% area)0.180.13
Water (%)4.25.28
Counter-ion (%)not stated5.92
Peptide content (%w/w)not stated88.28
Endotoxin (EU/mg)not stated0.31
Method stated on certificateYES—column, 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
Laboratory-retained
Evidentiary weight
Provenance documented, selection uncontrolled.
Chain of custody
Laboratory retained sample (−20 °C, 12 d since original receipt) → re-assay.
Assay date
06 Dec 2025
Submitted to the index
24 Dec 2025
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.

ppm_error
Well inside class limit. Worth noting that the class limits are set by mass rather than globally, because the same ppm is a different number of daltons at 340 and at 4,800.
dimer_disulfide
Any covalent dimer would appear at roughly twice the parent mass, and on a cysteine-containing sequence at twice the parent minus two hydrogens. The envelope on this record shows no series at either offset.
Section 7

Related records

Same batch — lot TFS-{CAT}-1157 n=11

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-018933TFS-{CAT}-1157PeptideMeter2025-Q499.765.09—Buyer-sourced1MARGINAL
AX-2025-018934TFS-{CAT}-1157PeptideMeter2025-Q499.825.16—Buyer-sourced0PASS
AX-2025-018935TFS-{CAT}-1157Janoshik2025-Q499.815.92101.6Buyer-sourced0PASS
AX-2026-041764TFS-{CAT}-1157PeptideMeter2025-Q499.935.62—Supplier-supplied0PASS
AX-2025-018936TFS-{CAT}-1157Kestrel2025-Q499.935.37—Buyer-sourced0PASS
AX-2025-018937TFS-{CAT}-1157Medutest2025-Q499.525.02—Buyer-sourced0PASS
AX-2025-018938TFS-{CAT}-1157Medutest2025-Q499.675.34—Buyer-sourced0PASS
AX-2025-018939TFS-{CAT}-1157Janoshik2025-Q499.715.34101.3Buyer-sourced0PASS
AX-2025-018941TFS-{CAT}-1157Janoshik2025-Q499.805.50100.4Buyer-sourced0PASS
AX-2025-018942TFS-{CAT}-1157Nordanalyt2025-Q499.935.47—Buyer-sourced0PASS

Cross-sections

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-Q399.546.34—Buyer-sourced1MARGINAL
AX-2026-043445BCHBCH-2603-G4350Nordanalyt2026-Q398.424.8793.6Buyer-sourced1MARGINAL
AX-2026-043440BCHBCH-2603-G4350VendorInvestigate2026-Q398.614.11—Buyer-sourced1MARGINAL
AX-2026-043442BCHBCH-2603-G4350Janoshik2026-Q398.654.78—Buyer-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 TFS records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041681CJC-1295 with DACTFS-{CAT}-9675PeptideMeter2026-Q398.823.67—Buyer-sourced0PASS
AX-2026-041766BPC-157TFS-{CAT}-1156Janoshik2026-Q399.546.34—Buyer-sourced1MARGINAL
AX-2026-041682CJC-1295 with DACTFS-{CAT}-9675Nordanalyt2026-Q398.943.24—Buyer-sourced0PASS
AX-2026-041683CJC-1295 with DACTFS-{CAT}-9675Medutest2026-Q398.683.4697.0Buyer-sourced0PASS
AX-2026-041765BPC-157TFS-{CAT}-1156Janoshik2026-Q399.796.01—Buyer-sourced0PASS
AX-2026-041680CJC-1295 with DACTFS-{CAT}-9675Medutest2026-Q399.182.85100.4Buyer-sourced0PASS
AX-2026-041691SemaglutideTFS-{CAT}-9744Janoshik2026-Q298.316.0791.4Buyer-sourced0PASS
AX-2026-041700SS-31 (Elamipretide)TFS-{CAT}-1142Medutest2026-Q299.752.2796.3Buyer-sourced0PASS