AssayIndex

AX-2026-043038

Retatrutide · 12 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2604-N4863

PASSVERIFIED
Report ID
AX-2026-043038
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot
KP-2604-N4863
Declared label claim
12mg
Laboratory
Janoshik Analytical
Assay date
22 Jun 2026
Submitted
25 Jun 2026
Quarter
2026-Q2
Submitter
c18_2p6
Sample provenance
Buyer-sourced
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 nm98.53% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.47% area≤ 3.5PASS
Largest single impurityRP-HPLC — [D-Aib2]-diastereomer0.59% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula4728.4871DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4728.4956DaNOT TESTED
Mass accuracyobserved vs theoretical+1.8ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance87.67%w/wNOT TESTED
Target-compound contenttotal peptide content × purity86.38%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen14.63mg12 mg declaredNOT TESTED
Recovered target peptidegross fill × target content12.637mg12 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim105.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.49%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography6.35%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.49%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 lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear after 90 s gentle swirling, no particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.062.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient20.57min20.71 ± 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)²53,685≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.60no 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.

01218243736554873 Retatrutide20.57 min · 98.53 % 20.3522.98 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 53,685, 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 98.53 % 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 peak20.574,788,86398.53
2[D-Aib2]-diastereomer20.3528,6760.590.000
3C18 diacid regioisomer21.1524,3020.500.000
4des-Aib20 analogue20.1312,1510.25-85.053
5oxidised Trp (+16 Da)19.913,8880.08+15.995
6incomplete Fmoc removal (+222 Da)22.981,4580.03+222.068
7aspartimide (−18 Da)21.289720.02-18.011
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+946.71[M+6H]6+789.09[M+4H]4+1183.13 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 4728.4956 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+676.5054676.50660.00128.5
6+789.0885789.08990.001455.2
5+946.7047946.70640.0017100.0
4+1183.12911183.13120.002153.2
3+1577.16961577.17250.00299.3
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 Fischer5.49
Counter-ion (TFA)ion chromatography6.35
Residual solvent + inorganic residueestimated0.49
Total peptide contentby difference87.67
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)98.1298.53divergence -0.34 pp vs batch median
Total impurities (% area)not stated1.47
Largest single impurity (% area)not stated0.59
Water (%)not stated5.49
Counter-ion (%)not stated6.35
Peptide content (%w/w)91.787.67
Endotoxin (EU/mg)1.42not determined
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
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Retail purchase → submitter (ambient, 20 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date
22 Jun 2026
Submitted to the index
25 Jun 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
Section 6

Annotations 1

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.

c18_2p6
Core-shell packing at 2.6 µm gains roughly 40 % in resolution over a 5 µm fully porous bed at the same length and pressure. On a pair this close, that is the difference between two peaks and one.
Section 7

Related records

Same batch — lot KP-2604-N4863 n=4

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043039KP-2604-N4863Janoshik2026-Q298.384.8294.3Buyer-sourced0PASS
AX-2026-043040KP-2604-N4863Janoshik2026-Q298.855.35104.0Supplier-supplied0PASS
AX-2026-043041KP-2604-N4863Janoshik2026-Q298.335.58Buyer-sourced0PASS
Other recent Retatrutide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042437HomopeptideHOMO-2605-V4718Nordanalyt2026-Q398.683.67102.8Buyer-sourced0PASS
AX-2026-043095KPKP-2607-H5774Janoshik2026-Q395.815.48105.2Buyer-sourced0FAIL
AX-2026-042282TFCTFC-2608-J1156Janoshik2026-Q398.544.27Buyer-sourced0PASS
AX-2026-043094KPKP-2607-H5774PeptideMeter2026-Q396.326.40Buyer-sourced0FAIL
AX-2026-042441HomopeptideHOMO-2605-V4718Medutest2026-Q398.934.22Buyer-sourced0PASS
AX-2026-041427QYBQYB-2604-B4920PeptideMeter2026-Q397.932.45101.7Buyer-sourced0PASS
AX-2026-041786ASYASY-{CAT}-2288VendorInvestigate2026-Q398.786.59Buyer-sourced0PASS
AX-2026-041428QYBQYB-2604-B4920Janoshik2026-Q398.353.20Laboratory-retained0PASS
Other recent KP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043095RetatrutideKP-2607-H5774Janoshik2026-Q395.815.48105.2Buyer-sourced0FAIL
AX-2026-043094RetatrutideKP-2607-H5774PeptideMeter2026-Q396.326.40Buyer-sourced0FAIL
AX-2026-043096RetatrutideKP-2607-H5774VendorInvestigate2026-Q396.486.05104.9Buyer-sourced0FAIL
AX-2026-043090RetatrutideKP-2607-H5774Janoshik2026-Q396.465.81Buyer-sourced0FAIL
AX-2026-043091RetatrutideKP-2607-H5774Janoshik2026-Q396.135.94Buyer-sourced0FAIL
AX-2026-043077TB-500KP-2605-C5214Janoshik2026-Q299.615.6490.2Buyer-sourced0PASS
AX-2026-043093RetatrutideKP-2607-H5774Janoshik2026-Q396.545.54Buyer-sourced0PASS
AX-2026-043092RetatrutideKP-2607-H5774Medutest2026-Q396.646.12Buyer-sourced1FAIL