AssayIndex

AX-2025-020072

IGF-1 LR3 · 0.1 mg declared · Shanghai Wibson Biotechnology Co., Ltd. · lot SWB-2505-N7884

MARGINALIDENTITY CONSISTENT
Report ID
AX-2025-020072
Compound
IGF-1 LR3
Compound class
Growth-hormone axis peptides
Supplier
SWB — Shanghai Wibson Biotechnology Co., Ltd.
Batch / lot
SWB-2505-N7884
Declared label claim
0.10mg
Laboratory
Medutest
Assay date
09 Nov 2025
Submitted
10 Nov 2025
Quarter
2025-Q4
Submitter
quarter_over_quarter
Sample provenance
Laboratory-retained
Section 1

Results

Measured against the index acceptance specification for the growth-hormone axis 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, 25 min gradient, 214 nm97.36% area≥ 95.0PASS
Total impuritiesRP-HPLC, sum of reported peaks2.64% area≤ 5.0PASS
Largest single impurityRP-HPLC — aggregated dimer1.18% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula9105.2412Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, unit resolution (single quadrupole)9105.2694Da—NOT TESTED
Mass accuracyobserved vs theoretical+3.1ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance88.27%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity85.94%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen0.10mg0.1 mg declaredNOT TESTED
Recovered target peptidegross fill × target content0.086mg0.1 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim86.0%90.0 – 110.0FAIL
Water contentKarl Fischer, coulometric, duplicate6.58%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography4.18%≤ 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 determined—no growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundOff-white 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 calibration4.94—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient14.17min14.33 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.98—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²34,881—≥ 20,000PASS
Resolution to nearest impurityvs disulfide-scrambled isomer1.66—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.

01500300145016002 IGF-1 LR314.17 min · 97.36 % 16.8414.6912.30 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0481216202428 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 25 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 34,881, and skew follows the reported asymmetry factor of 0.98. 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 1.18 % impurity against a 97.36 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1IGF-1 LR3 — main peak14.174,731,99897.36—
2aggregated dimer16.8457,3521.18+9105.241
3disulfide-scrambled isomer14.6934,5080.710.000
4oxidised Met59 (+16 Da)13.5722,8430.47+15.995
5des-13-residue N-extension (native IGF-1)12.308,2630.17-1441.712
6truncated (1-70)12.555,3460.11-1385.688
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 9105.2412 Da, computed from C400H625N111O116S9. All ppm figures on this site are against monoisotopic values — see why that matters.

02550751007508509501050115012501350 [M+9H]9+1012.70[M+10H]10+911.53[M+8H]8+1139.17 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 9105.2694 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 (%)
11+828.7565828.75900.00258.7
10+911.5314911.53420.002857.6
9+1012.70071012.70390.0032100.0
8+1139.16241139.16600.003653.9
7+1301.75601301.76000.00408.0
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 Fischer6.58
Counter-ion (acetate)ion chromatography4.18
Residual solvent + inorganic residueestimated0.97
Total peptide contentby difference88.27
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)97.3097.36divergence +0.07 pp vs batch median
Total impurities (% area)2.702.64
Largest single impurity (% area)not stated1.18
Water (%)6.16.58
Counter-ion (%)not stated4.18
Peptide content (%w/w)not stated88.27
Endotoxin (EU/mg)not statednot determined
Method stated on certificateNO—no 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
Laboratory-retained
Evidentiary weight
Provenance documented, selection uncontrolled.
Chain of custody
Laboratory retained sample (−20 °C, 1 d since original receipt) → re-assay.
Assay date
09 Nov 2025
Submitted to the index
10 Nov 2025
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-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.

lambda_214
Detection wavelength does not affect a mass determination but it does affect the purity figure sitting next to it. Both are stated on this record, which is the point.
underfill_3to1
Purity at 97.36 % and recovery at 86.0 % are independent findings. High purity and low recovery is a formulation and fill result, not a synthesis one.
Section 7

Related records

Same batch — lot SWB-2505-N7884 n=12

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020073SWB-2505-N7884Kestrel2025-Q498.636.0894.0Buyer-sourced0PASS
AX-2025-020074SWB-2505-N7884VendorInvestigate2025-Q497.126.52103.0Buyer-sourced0PASS
AX-2025-020075SWB-2505-N7884Janoshik2025-Q497.586.05—Buyer-sourced0PASS
AX-2025-020076SWB-2505-N7884Janoshik2025-Q497.086.47101.0Buyer-sourced0PASS
AX-2025-020077SWB-2505-N7884Janoshik2025-Q497.225.99—Buyer-sourced0PASS
AX-2025-020078SWB-2505-N7884Janoshik2025-Q497.026.3193.0Buyer-sourced0PASS
AX-2025-020079SWB-2505-N7884PeptideMeter2025-Q497.237.01100.0Buyer-sourced0PASS
AX-2025-020080SWB-2505-N7884Janoshik2025-Q497.186.5993.0Buyer-sourced0PASS
AX-2025-020081SWB-2505-N7884Janoshik2025-Q497.256.4894.0Buyer-sourced0PASS
AX-2025-020082SWB-2505-N7884Medutest2025-Q497.586.64—Buyer-sourced0PASS
AX-2026-042667SWB-2505-N7884Janoshik2025-Q496.817.0392.0Buyer-sourced0PASS

Cross-sections

Other recent IGF-1 LR3 records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042503HomopeptideHOMO-2607-P5131Janoshik2026-Q399.365.99—Buyer-sourced0PASS
AX-2026-042509HomopeptideHOMO-2607-P5131Medutest2026-Q398.636.23103.0Buyer-sourced0PASS
AX-2026-041930SinoPepSNP-2606-D4620Medutest2026-Q398.545.3793.8Buyer-sourced0PASS
AX-2026-041931SinoPepSNP-2606-D4620PeptideMeter2026-Q397.935.1993.4Buyer-sourced0PASS
AX-2026-041924SinoPepSNP-2606-D4620Janoshik2026-Q397.955.34—Buyer-sourced0PASS
AX-2026-042504HomopeptideHOMO-2607-P5131Janoshik2026-Q399.086.26105.0Buyer-sourced0PASS
AX-2026-042499HomopeptideHOMO-2607-P5131Medutest2026-Q398.485.9888.0Buyer-sourced1MARGINAL
AX-2026-042508HomopeptideHOMO-2607-P5131Janoshik2026-Q398.896.22—Buyer-sourced1MARGINAL
Other recent SWB records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042637SemaglutideSWB-2602-X7905Janoshik2026-Q398.374.26102.9Buyer-sourced0PASS
AX-2026-042645SemaglutideSWB-2602-X7905Medutest2026-Q398.484.5295.2Buyer-sourced0PASS
AX-2026-042642SemaglutideSWB-2602-X7905PeptideMeter2026-Q397.964.4890.8Buyer-sourced0PASS
AX-2026-042640SemaglutideSWB-2602-X7905PeptideMeter2026-Q398.554.29—Buyer-sourced0PASS
AX-2026-042638SemaglutideSWB-2602-X7905Janoshik2026-Q398.743.65—Buyer-sourced0PASS
AX-2026-042639SemaglutideSWB-2602-X7905Janoshik2026-Q398.774.21—Supplier-supplied0PASS
AX-2026-042641SemaglutideSWB-2602-X7905Janoshik2026-Q398.864.4899.1Buyer-sourced0PASS
AX-2026-042644SemaglutideSWB-2602-X7905PeptideMeter2026-Q398.763.5797.7Buyer-sourced0PASS