AssayIndex

AX-2026-043630

Ipamorelin · 10 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2510-B5567

FAILIDENTITY CONSISTENT
Report ID
AX-2026-043630
Compound
Ipamorelin
Compound class
Growth-hormone axis peptides
Supplier
WXT — WuXi TIDES (WuXi AppTec Testing Division)
Batch / lot
WXT-2510-B5567
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
10 Dec 2025
Submitted
04 Jan 2026
Quarter
2025-Q4
Submitter
am.ekstrom
Sample provenance
Supplier-supplied
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, 30 min gradient, 214 nm98.60% area≥ 99.0FAIL
Total impuritiesRP-HPLC, sum of reported peaks1.40% area≤ 1.0FAIL
Largest single impurityRP-HPLC — des-Lys (−128 Da)0.97% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula711.3856DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)711.3874DaNOT TESTED
Mass accuracyobserved vs theoretical+2.6ppm± 15PASS
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate3.65%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography7.28%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.28%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 to pale-yellow cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear with a single visible fibreclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration6.062.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient8.27min8.24 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.060.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²74,558≥ 20,000PASS
Resolution to nearest impurityvs [D-Trp]-epimer0.97no 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.

0365973171097614635 Ipamorelin8.27 min · 98.60 % 8.05 same trace · ×50 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 74,558, and skew follows the reported asymmetry factor of 1.06. 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 0.97 % impurity against a 98.60 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Ipamorelin — main peak8.274,792,26698.60
2des-Lys (−128 Da)8.0547,1450.97-128.095
3oxidised Trp (+16 Da)7.9312,1510.25+15.995
4[D-Trp]-epimer8.154,8600.100.000
5Aib-deletion sequence (−85 Da)7.992,4300.05-85.053
6C-terminal free acid (+1 Da)8.451,4580.03+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 711.3856 Da, computed from C38H49N9O5. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100300375450525600675750 [M+1H]1+712.39[M+2H]2+356.70 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 711.3874 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+356.7001356.70100.000953.1
1+712.3929712.39470.0018100.0
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)98.0498.60divergence -0.47 pp vs batch median
Total impurities (% area)1.961.40
Largest single impurity (% area)not stated0.97
Water (%)2.73.65
Counter-ion (%)not stated7.28
Peptide content (%w/w)92.5not 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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 3 d) → assay. Submitter did not handle the vial.
Assay date
10 Dec 2025
Submitted to the index
04 Jan 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
IDENTITY CONSISTENT
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.

multiple_compare
Sixty-six compounds and twenty suppliers is a lot of cells. Some records will sit below specification by chance alone, and a single one is not a supplier finding. The per-compound table on the scorecard is the correct denominator.
mass_defect
Identity confirmed, purity 98.60 %, mass balance closed. This record is complete against the index definition of complete and there is nothing outstanding on it.
survivor_lots
A supplier sending a sample chooses a lot as well as a vial. Both selections point the same way and neither is separable from the other in a single record.
Section 7

Related records

Same batch — lot WXT-2510-B5567 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-021229WXT-2510-B5567Janoshik2025-Q499.214.05106.3Supplier-supplied0PASS
AX-2025-021230WXT-2510-B5567VendorInvestigate2025-Q498.903.87Buyer-sourced0FAIL
AX-2025-021231WXT-2510-B5567Janoshik2025-Q498.383.14Supplier-supplied0FAIL
AX-2025-021232WXT-2510-B5567Janoshik2025-Q498.363.72Buyer-sourced0FAIL
AX-2025-021233WXT-2510-B5567PeptideMeter2025-Q498.583.7699.1Buyer-sourced0FAIL
AX-2025-021234WXT-2510-B5567Janoshik2025-Q498.513.5494.8Buyer-sourced0FAIL
AX-2025-021235WXT-2510-B5567Janoshik2025-Q498.053.3594.9Buyer-sourced0FAIL
AX-2025-021236WXT-2510-B5567Janoshik2025-Q498.083.8893.8Buyer-sourced0FAIL
Other recent Ipamorelin records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042346HomopeptideHOMO-2608-A2117Medutest2026-Q399.065.05Buyer-sourced0PASS
AX-2026-042347HomopeptideHOMO-2608-A2117Medutest2026-Q399.794.90Buyer-sourced0PASS
AX-2026-041411QYBQYB-2605-H4076Janoshik2026-Q399.863.5990.6Buyer-sourced0PASS
AX-2026-041410QYBQYB-2605-H4076Medutest2026-Q399.874.58101.5Laboratory-retained1FAIL
AX-2026-042351HomopeptideHOMO-2608-A2117VendorInvestigate2026-Q399.155.02100.1Buyer-sourced0PASS
AX-2026-041408QYBQYB-2605-H4076Kestrel2026-Q399.934.49Buyer-sourced1FAIL
AX-2026-042350HomopeptideHOMO-2608-A2117Kestrel2026-Q399.934.7492.5Laboratory-retained0PASS
AX-2026-043245KPKP-2606-D6960PeptideMeter2026-Q399.253.42Buyer-sourced0PASS
Other recent WXT records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043651PramlintideWXT-2603-D6459PeptideMeter2026-Q398.214.97101.6Buyer-sourced1MARGINAL
AX-2026-043531LeuprolideWXT-2604-K4483Medutest2026-Q399.005.03Buyer-sourced0PASS
AX-2026-043561SemaglutideWXT-2604-C5135Janoshik2026-Q396.964.2291.3Buyer-sourced0FAIL
AX-2026-043627L-Glutathione (reduced)WXT-2605-B5720Janoshik2026-Q397.966.0892.3Buyer-sourced1FAIL
AX-2026-043564SemaglutideWXT-2604-C5135Janoshik2026-Q397.154.44104.7Buyer-sourced0PASS
AX-2026-043533LeuprolideWXT-2604-K4483PeptideMeter2026-Q399.894.94Supplier-supplied0PASS
AX-2026-043624L-Glutathione (reduced)WXT-2605-B5720Nordanalyt2026-Q398.186.95105.3Buyer-sourced2FAIL
AX-2026-043556SemaglutideWXT-2604-C5135PeptideMeter2026-Q397.564.3589.6Buyer-sourced1MARGINAL