AssayIndex

AX-2026-041612

TB-500 · 10 mg declared · Flourishglobal Peptide Biotech (Chengdu) Co., Ltd. · lot FGP-2512-Y7789

PASSIDENTITY CONSISTENT
Report ID
AX-2026-041612
Compound
TB-500
Compound class
Tissue-repair and immunomodulatory peptides
Supplier
FGP — Flourishglobal Peptide Biotech (Chengdu) Co., Ltd.
Batch / lot
FGP-2512-Y7789
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
25 Jun 2026
Submitted
15 Jul 2026
Quarter
2026-Q2
Submitter
Contributor #J-7530
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 nm99.93% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.07% area≤ 1.5PASS
Largest single impurityRP-HPLC — [D-Thr]-diastereomer0.04% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula887.4964DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)887.5019DaNOT TESTED
Mass accuracyobserved vs theoretical+6.2ppm± 15PASS
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate4.39%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography4.58%≤ 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 powder, no defined cake (melt-back)white 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 calibration4.352.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient7.96min7.86 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.960.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²65,463≥ 20,000PASS
Resolution to nearest impurityvs [D-Thr]-diastereomer0.86no 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.

0379475881138215176 TB-5007.96 min · 99.93 % 7.85 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 65,463, and skew follows the reported asymmetry factor of 0.96. 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 0.04 % impurity against a 99.93 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1TB-500 — main peak7.964,856,90899.93
2[D-Thr]-diastereomer7.851,9440.040.000
3C-terminal amide (−1 Da)8.141,4580.03-0.984
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 887.4964 Da, computed from C39H69N9O14. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100375475575675775875975 [M+1H]1+888.51[M+2H]2+444.76 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 887.5019 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 (%)
2+444.7555444.75820.002753.3
1+888.5037888.50920.0055100.0
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.

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)99.9099.93divergence +0.05 pp vs batch median
Total impurities (% area)0.100.07
Largest single impurity (% area)not stated0.04
Water (%)2.34.39
Counter-ion (%)not stated4.58
Peptide content (%w/w)92.9not determined
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, 3 d) → laboratory (courier, ambient, 9 d) → assay.
Assay date
25 Jun 2026
Submitted to the index
15 Jul 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
IDENTITY CONSISTENT
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.

c18_2p6
Column chemistry flatters or punishes a figure like this. A core-shell column at this gradient resolves the close-eluting family that a fully porous 5 µm bed merges, so 99.93 % here is a harder number than the same figure from a coarser column.
gradient_25
The gradient is on the record, which is the first thing that should be true of any purity figure and often is not. 30 min at Janoshik puts this comparison on a documented footing.
Section 7

Related records

Same batch — lot FGP-2512-Y7789 n=7

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041611FGP-2512-Y7789Janoshik2026-Q299.844.62102.9Buyer-sourced0PASS
AX-2026-041613FGP-2512-Y7789Janoshik2026-Q299.893.82Buyer-sourced0PASS
AX-2026-041614FGP-2512-Y7789Medutest2026-Q299.853.74Buyer-sourced0PASS
AX-2026-041615FGP-2512-Y7789PeptideMeter2026-Q299.854.21Buyer-sourced0PASS
AX-2026-041616FGP-2512-Y7789Medutest2026-Q299.933.8297.4Buyer-sourced0PASS
AX-2026-041617FGP-2512-Y7789VendorInvestigate2026-Q299.574.4999.6Buyer-sourced0PASS
Other recent TB-500 records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041776ASYASY-{CAT}-2167Janoshik2026-Q399.924.6198.2Buyer-sourced0PASS
AX-2026-041777ASYASY-{CAT}-2167PeptideMeter2026-Q399.784.0992.8Buyer-sourced0PASS
AX-2026-041782ASYASY-{CAT}-2167Nordanalyt2026-Q399.933.94Buyer-sourced0PASS
AX-2026-041774ASYASY-{CAT}-2167PeptideMeter2026-Q399.934.4196.2Buyer-sourced0PASS
AX-2026-042127JEEPJEEP-2602-V8614Medutest2026-Q399.683.55Buyer-sourced1FAIL
AX-2026-042021AMBAMB-2602-P5987VendorInvestigate2026-Q399.864.79101.4Buyer-sourced0PASS
AX-2026-041780ASYASY-{CAT}-2167Janoshik2026-Q399.933.48102.5Buyer-sourced1FAIL
AX-2026-041779ASYASY-{CAT}-2167Janoshik2026-Q399.843.85Buyer-sourced1FAIL
Other recent FGP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041643SemaglutideFGP-2602-M8547Janoshik2026-Q399.312.79100.7Buyer-sourced0PASS
AX-2026-041638SemaglutideFGP-2602-M8547Janoshik2026-Q399.402.75105.8Buyer-sourced0PASS
AX-2026-041641SemaglutideFGP-2602-M8547PeptideMeter2026-Q398.982.38105.0Buyer-sourced0PASS
AX-2026-041610TirzepatideFGP-2603-L7753Janoshik2026-Q398.812.45101.0Buyer-sourced0PASS
AX-2026-041637SemaglutideFGP-2602-M8547PeptideMeter2026-Q399.402.83Laboratory-retained0PASS
AX-2026-041642SemaglutideFGP-2602-M8547PeptideMeter2026-Q398.782.24Buyer-sourced0PASS
AX-2026-041609TirzepatideFGP-2603-L7753Janoshik2026-Q398.522.0098.0Buyer-sourced0PASS
AX-2026-041636SemaglutideFGP-2602-M8547Nordanalyt2026-Q399.392.17Buyer-sourced0PASS