AssayIndex

AX-2026-041725

TB-500 · 5 mg declared · Thermo Fisher Scientific (China) Co., Ltd. · lot TFS-{CAT}-9979

FAILPURITY ONLY
Report ID
AX-2026-041725
Compound
TB-500
Compound class
Tissue-repair and immunomodulatory peptides
Supplier
TFS — Thermo Fisher Scientific (China) Co., Ltd.
Batch / lot
TFS-{CAT}-9979
Declared label claim
5mg
Laboratory
Nordanalyt Laboratories
Assay date
25 Feb 2026
Submitted
23 Mar 2026
Quarter
2026-Q1
Submitter
an.aguirre
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, 35 min gradient, 214 nm99.93% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.07% area≤ 1.5PASS
Largest single impurityRP-HPLC — des-acetyl TB-500 (−42 Da)0.04% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance91.91%w/wNOT TESTED
Target-compound contenttotal peptide content × purity91.85%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen5.11mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content4.694mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim93.9%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate3.10%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography4.15%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.84%NOT TESTED
Endotoxinkinetic chromogenic LAL5.10EU/mg≤ 5.0FAIL
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 calibration6.052.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient9.10min9.07 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.200.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²58,549≥ 20,000PASS
Resolution to nearest impurityvs des-Gln truncate (−128 Da)1.82no 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.

027965592838911185 TB-5009.10 min · 99.93 % 8.49 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0510152025303540 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 35 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 58,549, and skew follows the reported asymmetry factor of 1.20. 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 peak9.104,856,90899.93
2des-acetyl TB-500 (−42 Da)8.491,9440.04-42.011
3des-Gln truncate (−128 Da)8.821,4580.03-128.059
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 Fischer3.10
Counter-ion (acetate)ion chromatography4.15
Residual solvent + inorganic residueestimated0.84
Total peptide contentby difference91.91
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)99.9099.93divergence +0.07 pp vs batch median
Total impurities (% area)0.100.07
Largest single impurity (% area)0.040.04
Water (%)2.83.10
Counter-ion (%)6.64.15
Peptide content (%w/w)90.091.91
Endotoxin (EU/mg)not stated5.10
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 (ambient, 12 d) → laboratory (hand-carried, 6 d) → assay.
Assay date
25 Feb 2026
Submitted to the index
23 Mar 2026
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 min gradient · high-resolution MS
Verification status
PURITY ONLY
Section 6

Annotations 4

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.

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.
price_per_mg
A retail purchase carries a price, which makes cost per milligram of recovered peptide computable. That is the comparison a buyer actually needs and it exists only for this provenance class.
low_n
Strong provenance does not fix small n. One well-sourced record is still one record, and the batch page says how many others exist for TFS-{CAT}-9979.
ash_sulfated
Four slots — water, counter-ion, residual and peptide — are exhaustive and mutually exclusive. Anything that does not fit one of them is a fifth thing nobody measured, and on this record there is no remainder.
Section 7

Related records

Same batch — lot TFS-{CAT}-9979 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041723TFS-{CAT}-9979Janoshik2026-Q199.723.97Buyer-sourced1FAIL
AX-2026-041724TFS-{CAT}-9979Janoshik2026-Q199.914.0190.1Buyer-sourced0PASS
AX-2026-041726TFS-{CAT}-9979Nordanalyt2026-Q199.834.45Buyer-sourced0PASS
AX-2026-041727TFS-{CAT}-9979PeptideMeter2026-Q199.624.28104.1Buyer-sourced0PASS
AX-2026-041728TFS-{CAT}-9979Janoshik2026-Q199.703.9794.8Buyer-sourced0PASS
AX-2026-041729TFS-{CAT}-9979Janoshik2026-Q199.933.62106.3Buyer-sourced1FAIL
AX-2026-041730TFS-{CAT}-9979Janoshik2026-Q199.934.12Buyer-sourced0PASS
AX-2026-041731TFS-{CAT}-9979Janoshik2026-Q199.353.9797.0Buyer-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 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