AssayIndex

AX-2026-043050

Hexarelin · 2 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2604-X5435

FAILIDENTITY CONSISTENT
Report ID
AX-2026-043050
Compound
Hexarelin
Compound class
Growth-hormone axis peptides
Supplier
KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot
KP-2604-X5435
Declared label claim
2mg
Laboratory
Medutest
Assay date
19 May 2026
Submitted
01 Jun 2026
Quarter
2026-Q2
Submitter
f.duarte
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, 25 min gradient, 214 nm98.56% area≥ 99.0FAIL
Total impuritiesRP-HPLC, sum of reported peaks1.44% area≤ 1.0FAIL
Largest single impurityRP-HPLC — C-terminal free acid (+1 Da)0.57% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula886.4602DaNOT TESTED
Identity — observed monoisotopic massLC-MS, unit resolution (single quadrupole)886.4554DaNOT TESTED
Mass accuracyobserved vs theoretical-5.4ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance89.67%w/wNOT TESTED
Target-compound contenttotal peptide content × purity88.38%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen2.36mg2 mg declaredNOT TESTED
Recovered target peptidegross fill × target content2.086mg2 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim104.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate3.25%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography6.93%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.15%NOT TESTED
Endotoxinkinetic chromogenic LAL6.53EU/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 after 90 s gentle swirling, no particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.552.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient7.62min7.55 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.120.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²62,316≥ 20,000PASS
Resolution to nearest impurityvs C-terminal free acid (+1 Da)1.07no 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.

0352670521057814104 Hexarelin7.62 min · 98.56 % 7.22 same trace · ×100 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 62,316, and skew follows the reported asymmetry factor of 1.12. 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 0.57 % impurity against a 98.56 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Hexarelin — main peak7.624,790,32298.56
2C-terminal free acid (+1 Da)7.7527,7040.57+0.984
3des-methyl hexarelin (GHRP-6, −14 Da)7.2227,2180.56-14.016
4des-Lys (−128 Da)7.449,7210.20-128.095
5oxidised Trp (+16 Da)7.345,3460.11+15.995
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 886.4602 Da, computed from C47H58N12O6. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100375475575675775875975 [M+1H]1+887.46[M+2H]2+444.24 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 886.4554 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+444.2374444.2350-0.002457.8
1+887.4675887.4627-0.0048100.0
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 Fischer3.25
Counter-ion (acetate)ion chromatography6.93
Residual solvent + inorganic residueestimated0.15
Total peptide contentby difference89.67
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)99.098.56divergence +0.45 pp vs batch median
Total impurities (% area)1.001.44
Largest single impurity (% area)0.500.57
Water (%)1.23.25
Counter-ion (%)4.06.93
Peptide content (%w/w)94.289.67
Endotoxin (EU/mg)not stated6.53
Method stated on certificateYEScolumn, 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
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
19 May 2026
Submitted to the index
01 Jun 2026
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-resolution MS
Verification status
IDENTITY CONSISTENT
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.

endotoxin_limit
Endotoxin burden at this level usually tracks water quality at the fill step rather than anything about the synthesis. A high-purity lot with high endotoxin is an entirely coherent result and this is one.
Endotoxin undetectable means below the detection limit of on Medutest's system. That does not mean zero and may not reflect actual endotoxin. The cutoff is useful for screening; the absence of a number is not a guarantee.
oxytocin_pheur
6.53 EU/mg is elevated relative to the index median and the record shows no depyrogenation step. If this material will be reconstituted in aqueous buffer for any downstream use, that endotoxin load is a risk.
coa_template
Endotoxin assay but no bacterial viability or total count. The two are independent: dead endotoxin-bearing bacteria contribute to the burden, living ones that produce endotoxins do not.
Section 7

Related records

Same batch — lot KP-2604-X5435 n=10

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043043KP-2604-X5435VendorInvestigate2026-Q298.543.33107.2Buyer-sourced2FAIL
AX-2026-043044KP-2604-X5435VendorInvestigate2026-Q298.003.78107.5Buyer-sourced2FAIL
AX-2026-043045KP-2604-X5435Janoshik2026-Q299.223.5599.0Supplier-supplied2MARGINAL
AX-2026-043046KP-2604-X5435Nordanalyt2026-Q299.003.50Supplier-supplied2MARGINAL
AX-2026-043047KP-2604-X5435Janoshik2026-Q298.713.22103.5Supplier-supplied2FAIL
AX-2026-043048KP-2604-X5435VendorInvestigate2026-Q298.283.1594.2Buyer-sourced2FAIL
AX-2026-043049KP-2604-X5435Nordanalyt2026-Q298.463.64103.0Buyer-sourced2FAIL
AX-2026-043051KP-2604-X5435Janoshik2026-Q299.103.16104.0Supplier-supplied2MARGINAL
AX-2026-043052KP-2604-X5435Janoshik2026-Q297.982.79Supplier-supplied2FAIL
Other recent Hexarelin records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041892JEEPJEEP-2608-Y4367Janoshik2026-Q399.553.6198.9Supplier-supplied1MARGINAL
AX-2026-041893JEEPJEEP-2608-Y4367PeptideMeter2026-Q399.443.58103.2Supplier-supplied0PASS
AX-2026-043049KPKP-2604-X5435Nordanalyt2026-Q298.463.64103.0Buyer-sourced2FAIL
AX-2026-043279CPCCPC-2511-F1491PeptideMeter2026-Q298.875.35Supplier-supplied2FAIL
AX-2026-042137HomopeptideHOMO-2602-R8195Janoshik2026-Q299.933.9490.6Supplier-supplied1MARGINAL
AX-2026-043048KPKP-2604-X5435VendorInvestigate2026-Q298.283.1594.2Buyer-sourced2FAIL
AX-2026-043274CPCCPC-2511-F1491PeptideMeter2026-Q298.895.10Supplier-supplied2FAIL
AX-2026-043046KPKP-2604-X5435Nordanalyt2026-Q299.003.50Supplier-supplied2MARGINAL
Other recent KP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043029RetatrutideKP-2607-H5219Medutest2026-Q395.455.71Supplier-supplied2FAIL
AX-2026-043030RetatrutideKP-2607-H5219Kestrel2026-Q395.976.9597.1Supplier-supplied2FAIL
AX-2026-043106TirzepatideKP-2608-D5921PeptideMeter2026-Q398.905.45105.4Supplier-supplied2MARGINAL
AX-2026-043108TirzepatideKP-2608-D5921Janoshik2026-Q399.705.45Supplier-supplied2MARGINAL
AX-2026-043039RetatrutideKP-2607-H5219Janoshik2026-Q396.145.62Supplier-supplied2FAIL
AX-2026-043100TirzepatideKP-2608-D5921VendorInvestigate2026-Q398.275.3194.4Buyer-sourced2MARGINAL
AX-2026-043090IpamorelinKP-2606-D5887Janoshik2026-Q398.183.07101.2Laboratory-retained1FAIL
AX-2026-043028RetatrutideKP-2607-H5219Janoshik2026-Q396.526.09Supplier-supplied2MARGINAL