AssayIndex

AX-2026-042960

Retatrutide · 12 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2604-N4308

MARGINALVERIFIED
Report ID
AX-2026-042960
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot
KP-2604-N4308
Declared label claim
12mg
Laboratory
Janoshik Analytical
Assay date
14 Apr 2026
Submitted
29 Apr 2026
Quarter
2026-Q2
Submitter
r.rasmussen
Sample provenance
Supplier-supplied
Section 1

Results

Measured against the index acceptance specification for the incretin analogues and co-agonists 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 nm98.81% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.19% area≤ 3.5PASS
Largest single impurityRP-HPLC — retatrutide dimer0.59% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula4728.4871DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4728.4696DaNOT TESTED
Mass accuracyobserved vs theoretical-3.7ppm± 15PASS
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate5.45%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography8.49%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.57%NOT TESTED
Endotoxinkinetic chromogenic LAL2.11EU/mg≤ 5.0PASS
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 dno growthPASS
Appearancevisual, diffuse light, black and white backgroundWhite powder, no defined cake (melt-back)white to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear with a single visible fibreclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.482.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient20.53min20.71 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.110.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²61,318≥ 20,000PASS
Resolution to nearest impurityvs des-Aib20 analogue1.29no 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.

01308261539235231 Retatrutide20.53 min · 98.81 % 24.6520.0922.94 same trace · ×100 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 61,318, and skew follows the reported asymmetry factor of 1.11. 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 0.59 % impurity against a 98.81 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Retatrutide — main peak20.534,802,47298.81
2retatrutide dimer24.6528,6760.59+4728.487
3des-Aib20 analogue20.0913,6090.28-85.053
4incomplete Fmoc removal (+222 Da)22.9410,6930.22+222.068
5oxidised Trp (+16 Da)19.872,9160.06+15.995
6C18 diacid regioisomer21.111,9440.040.000
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 4728.4871 Da, computed from C221H342N46O68. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100550750950115013501550 [M+5H]5+946.70[M+6H]6+789.09[M+4H]4+1183.12 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 4728.4696 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 (%)
7+676.5054676.5029-0.00258.7
6+789.0885789.0855-0.003059.8
5+946.7047946.7012-0.0035100.0
4+1183.12911183.1247-0.004458.8
3+1577.16961577.1638-0.00588.4
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)99.098.81divergence +0.44 pp vs batch median
Total impurities (% area)1.001.19
Largest single impurity (% area)0.580.59
Water (%)4.75.45
Counter-ion (%)8.38.49
Peptide content (%w/w)86.4not determined
Endotoxin (EU/mg)not stated2.11
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, 10 d) → assay. Submitter did not handle the vial.
Assay date
14 Apr 2026
Submitted to the index
29 Apr 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
Section 6

Annotations

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot KP-2604-N4308 n=10

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042957KP-2604-N4308Janoshik2026-Q298.154.8796.8Supplier-supplied2MARGINAL
AX-2026-042958KP-2604-N4308Medutest2026-Q298.676.12Laboratory-retained2MARGINAL
AX-2026-042959KP-2604-N4308Janoshik2026-Q298.554.88Supplier-supplied2MARGINAL
AX-2026-042961KP-2604-N4308Janoshik2026-Q298.295.67Buyer-sourced2MARGINAL
AX-2026-042962KP-2604-N4308PeptideMeter2026-Q298.675.36103.9Supplier-supplied2MARGINAL
AX-2026-042963KP-2604-N4308Nordanalyt2026-Q298.575.08Supplier-supplied2MARGINAL
AX-2026-042964KP-2604-N4308Janoshik2026-Q298.244.87Buyer-sourced2MARGINAL
AX-2026-042965KP-2604-N4308Janoshik2026-Q298.155.64Supplier-supplied2MARGINAL
AX-2026-042966KP-2604-N4308VendorInvestigate2026-Q298.595.46106.2Buyer-sourced2MARGINAL
Other recent Retatrutide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043029KPKP-2607-H5219Medutest2026-Q395.455.71Supplier-supplied2FAIL
AX-2026-043030KPKP-2607-H5219Kestrel2026-Q395.976.9597.1Supplier-supplied2FAIL
AX-2026-041453QYBQYB-2604-B5660VendorInvestigate2026-Q398.022.55Buyer-sourced1MARGINAL
AX-2026-041454QYBQYB-2604-B5660Janoshik2026-Q398.842.77Supplier-supplied1MARGINAL
AX-2026-041538QYBQYB-2602-G6308Medutest2026-Q398.502.85Supplier-supplied2MARGINAL
AX-2026-041456QYBQYB-2604-B5660Janoshik2026-Q398.233.24Supplier-supplied1MARGINAL
AX-2026-041452QYBQYB-2604-B5660Nordanalyt2026-Q398.503.36Supplier-supplied1MARGINAL
AX-2026-043039KPKP-2607-H5219Janoshik2026-Q396.145.62Supplier-supplied2FAIL
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