AssayIndex

AX-2025-018939

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

PASSPURITY ONLY
Report ID
AX-2025-018939
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
26 Dec 2025
Quarter
2025-Q4
Submitter
h.zamora
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 nm99.71% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.29% area≤ 2.0PASS
Largest single impurityRP-HPLC — des-Gly truncate (−57 Da)0.19% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance87.97%w/wNOT TESTED
Target-compound contenttotal peptide content × purity87.71%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen2.31mg2 mg declaredNOT TESTED
Recovered target peptidegross fill × target content2.026mg2 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim101.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.34%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography5.91%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.78%NOT TESTED
Endotoxinkinetic chromogenic LAL0.12EU/mg≤ 5.0PASS
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 dno growthPASS
Appearancevisual, diffuse light, black and white backgroundWhite lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.652.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient9.62min9.62 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.190.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²69,811≥ 20,000PASS
Resolution to nearest impurityvs pyroglutamate cyclisation (−17 Da)2.08no 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.

028955790868511580 BPC-1579.62 min · 99.71 % 9.28 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 69,811, and skew follows the reported asymmetry factor of 1.19. 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 0.19 % impurity against a 99.71 % 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 peak9.624,846,21599.71
2des-Gly truncate (−57 Da)9.289,2350.19-57.021
3truncated (1-12)8.663,4020.07-285.132
4acetylated N-terminus (+42 Da)10.109720.02+42.011
5pyroglutamate cyclisation (−17 Da)9.934860.01-17.027
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 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 Fischer5.34
Counter-ion (acetate)ion chromatography5.91
Residual solvent + inorganic residueestimated0.78
Total peptide contentby difference87.97
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)99.5299.71divergence -0.28 pp vs batch median
Total impurities (% area)0.480.29
Largest single impurity (% area)0.180.19
Water (%)4.25.34
Counter-ion (%)not stated5.91
Peptide content (%w/w)not stated87.97
Endotoxin (EU/mg)not stated0.12
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 (−20 °C, 8 d) → laboratory (courier, dry ice, 6 d) → assay.
Assay date
06 Dec 2025
Submitted to the index
26 Dec 2025
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
PURITY ONLY
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.

prep_hplc_cut
0.29 % total impurities on BPC-157 means the preparative fraction was cut narrow. That trades yield for purity, and the trade was made in the buyer's favour on this lot.
Alkylation artefacts from a scavenger-poor cleavage would appear as a +58 or +76 family here. Absent, which says the cleavage was run properly.
buyer_sourced
Independently purchased, at the submitter's own cost, forwarded without the supplier's involvement. That is the definition and this record meets it.
Section 7

Related records

Same batch — lot TFS-{CAT}-1157 n=11

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-018933TFS-{CAT}-1157PeptideMeter2025-Q499.765.09Buyer-sourced1MARGINAL
AX-2025-018934TFS-{CAT}-1157PeptideMeter2025-Q499.825.16Buyer-sourced0PASS
AX-2025-018935TFS-{CAT}-1157Janoshik2025-Q499.815.92101.6Buyer-sourced0PASS
AX-2026-041764TFS-{CAT}-1157PeptideMeter2025-Q499.935.62Supplier-supplied0PASS
AX-2025-018936TFS-{CAT}-1157Kestrel2025-Q499.935.37Buyer-sourced0PASS
AX-2025-018937TFS-{CAT}-1157Medutest2025-Q499.525.02Buyer-sourced0PASS
AX-2025-018938TFS-{CAT}-1157Medutest2025-Q499.675.34Buyer-sourced0PASS
AX-2025-018940TFS-{CAT}-1157Janoshik2025-Q499.725.2892.0Laboratory-retained0PASS
AX-2025-018941TFS-{CAT}-1157Janoshik2025-Q499.805.50100.4Buyer-sourced0PASS
AX-2025-018942TFS-{CAT}-1157Nordanalyt2025-Q499.935.47Buyer-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 TFS records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041681CJC-1295 with DACTFS-{CAT}-9675PeptideMeter2026-Q398.823.67Buyer-sourced0PASS
AX-2026-041766BPC-157TFS-{CAT}-1156Janoshik2026-Q399.546.34Buyer-sourced1MARGINAL
AX-2026-041682CJC-1295 with DACTFS-{CAT}-9675Nordanalyt2026-Q398.943.24Buyer-sourced0PASS
AX-2026-041683CJC-1295 with DACTFS-{CAT}-9675Medutest2026-Q398.683.4697.0Buyer-sourced0PASS
AX-2026-041765BPC-157TFS-{CAT}-1156Janoshik2026-Q399.796.01Buyer-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