AssayIndex

AX-2026-043499

Ipamorelin · 5 mg declared · Sigma-Aldrich (Shanghai) Trading Co., Ltd. · lot SIG-2511-5466

MARGINALPURITY ONLY
Report ID
AX-2026-043499
Compound
Ipamorelin
Compound class
Growth-hormone axis peptides
Supplier
SIG — Sigma-Aldrich (Shanghai) Trading Co., Ltd.
Batch / lot
SIG-2511-5466
Declared label claim
5mg
Laboratory
Kestrel Bioanalytical
Assay date
06 May 2026
Submitted
15 May 2026
Quarter
2026-Q2
Submitter
m.beaulieu
Sample provenance
Buyer-sourced
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, 15 min gradient, 214 nm99.73% area≥ 99.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.27% area≤ 1.0PASS
Largest single impurityRP-HPLC — oxidised Trp (+16 Da)0.16% area≤ 1.00PASS
Identitynot ordered on this submissionnot determined—required for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance87.82%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity87.58%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen5.67mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content4.966mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim99.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.56%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography7.32%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.30%—NOT TESTED
Endotoxinkinetic chromogenic LAL0.80EU/mg≤ 5.0PASS
Sterilitynot ordered on this submissionnot determined—no growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite cake, partial shrinkage from vial wall—white to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureVisible particulates, did not clear—clear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.69—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 15 min gradient4.50min4.45 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.86—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²101,276—≥ 20,000PASS
Resolution to nearest impurityvs [D-Trp]-epimer1.03—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.

08594171882578234375 Ipamorelin4.50 min · 99.73 % 4.33 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 048121620 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 15 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 101,276, and skew follows the reported asymmetry factor of 0.86. 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 0.16 % impurity against a 99.73 % 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 peak4.504,847,18799.73—
2oxidised Trp (+16 Da)4.337,7760.16+15.995
3[D-Trp]-epimer4.443,4020.070.000
4C-terminal free acid (+1 Da)4.599720.02+0.984
5des-Lys (−128 Da)4.399720.02-128.095
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 Fischer4.56
Counter-ion (acetate)ion chromatography7.32
Residual solvent + inorganic residueestimated0.30
Total peptide contentby difference87.82
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)99.7799.73divergence +0.41 pp vs batch median
Total impurities (% area)0.090.27
Largest single impurity (% area)0.230.16
Water (%)not stated4.56
Counter-ion (%)not stated7.32
Peptide content (%w/w)91.787.82
Endotoxin (EU/mg)0.300.80
Method stated on certificateYES—column, 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 (ambient, 11 d) → laboratory (courier, cold pack, 9 d) → assay.
Assay date
06 May 2026
Submitted to the index
15 May 2026
Laboratory
Kestrel Bioanalytical, Melbourne, Australia
Method basis
15 min gradient · unit-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.

des_gly
At 99.73 % the deletion-sequence family is at or below the reporting threshold. On a sequence with a hindered coupling that is a statement about coupling efficiency, and a good one.
buyer_sourced
Buyer-sourced through an ordinary retail order, so the supplier had no opportunity to select the vial. This is the provenance class the index weights and it is roughly 87 % of the dataset.
shipping_temp
The custody block above records the shipping conditions this vial actually experienced, which is the condition an ordinary buyer's vial experiences too. That representativeness is the point.
Section 7

Related records

Same batch — lot SIG-2511-5466 n=2

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043500SIG-2511-5466VendorInvestigate2026-Q298.984.50—Buyer-sourced1FAIL

Cross-sections

Other recent Ipamorelin records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041377QYBQYB-2605-H3558Nordanalyt2026-Q399.934.35—Buyer-sourced0PASS
AX-2026-041913SinoPepSNP-2606-L4478PeptideMeter2026-Q398.885.28—Buyer-sourced0FAIL
AX-2026-041914SinoPepSNP-2606-L4478Janoshik2026-Q399.145.49—Buyer-sourced0PASS
AX-2026-041909SinoPepSNP-2606-L4478PeptideMeter2026-Q399.005.4889.5Buyer-sourced1MARGINAL
AX-2026-041895SinoPepSNP-2602-B3833Janoshik2026-Q399.934.72105.9Buyer-sourced1MARGINAL
AX-2026-041898SinoPepSNP-2602-B3833Nordanalyt2026-Q399.934.5496.0Buyer-sourced1MARGINAL
AX-2026-041899SinoPepSNP-2602-B3833PeptideMeter2026-Q399.934.9690.1Buyer-sourced1MARGINAL
AX-2026-041891SinoPepSNP-2602-B3833Janoshik2026-Q399.935.11—Buyer-sourced1MARGINAL
Other recent SIG records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043535GHRP-2SIG-2603-6031Janoshik2026-Q399.121.26105.7Buyer-sourced0PASS
AX-2026-043541GHRP-2SIG-2603-6031PeptideMeter2026-Q399.062.08107.4Buyer-sourced1MARGINAL
AX-2026-043539GHRP-2SIG-2603-6031Janoshik2026-Q398.951.74100.4Buyer-sourced1FAIL
AX-2026-043534GHRP-2SIG-2603-6031Medutest2026-Q399.112.1589.8Buyer-sourced1MARGINAL
AX-2026-043542GHRP-2SIG-2603-6031VendorInvestigate2026-Q399.051.43—Buyer-sourced1FAIL
AX-2026-043543GHRP-2SIG-2603-6031Janoshik2026-Q399.381.7098.6Buyer-sourced0PASS
AX-2026-043544GHRP-2SIG-2603-6031PeptideMeter2026-Q399.571.51105.4Buyer-sourced0PASS
AX-2026-043538GHRP-2SIG-2603-6031Kestrel2026-Q398.931.72—Buyer-sourced0FAIL