AssayIndex

AX-2026-043033

Retatrutide · 10 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2607-H5219

FAILVERIFIED
Report ID
AX-2026-043033
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot
KP-2607-H5219
Declared label claim
10mg
Laboratory
VendorInvestigate
Assay date
03 Aug 2026
Submitted
07 Aug 2026
Quarter
2026-Q3
Submitter
ai.krastev
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, 32 min gradient, 214 nm95.54% area≥ 96.5FAIL
Total impuritiesRP-HPLC, sum of reported peaks4.46% area≤ 3.5FAIL
Largest single impurityRP-HPLC — C18 diacid regioisomer2.15% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula4728.4871DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4728.4838DaNOT TESTED
Mass accuracyobserved vs theoretical-0.7ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance83.72%w/wNOT TESTED
Target-compound contenttotal peptide content × purity79.99%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen11.48mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content9.183mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim91.8%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.77%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography9.91%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.60%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 backgroundOff-white lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.982.5 – 8.0PASS
Retention time (observed)RP-HPLC, 32 min gradient21.91min21.98 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.230.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²64,903≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.67no 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.

01155230934644618 Retatrutide21.91 min · 95.54 % 22.5319.8624.48 same trace · ×20 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 32 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 64,903, and skew follows the reported asymmetry factor of 1.23. 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 2.15 % impurity against a 95.54 % 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 peak21.914,643,54095.54
2C18 diacid regioisomer22.53104,4972.150.000
3[D-Aib2]-diastereomer21.6862,2121.280.000
4des-Aib20 analogue21.4422,8430.47-85.053
5truncated (5-39)19.8615,0670.31-428.201
6aspartimide (−18 Da)22.676,8040.14-18.011
7incomplete Fmoc removal (+222 Da)24.485,3460.11+222.068
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+4H]4+1183.13[M+6H]6+789.09 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 4728.4838 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+676.5054676.5050-0.00048.4
6+789.0885789.0879-0.000655.1
5+946.7047946.7040-0.0007100.0
4+1183.12911183.1282-0.000957.8
3+1577.16961577.1685-0.00118.2
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 Fischer5.77
Counter-ion (TFA)ion chromatography9.91
Residual solvent + inorganic residueestimated0.60
Total peptide contentby difference83.72
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)96.3795.54divergence +0.23 pp vs batch median
Total impurities (% area)3.634.46
Largest single impurity (% area)not stated2.15
Water (%)3.45.77
Counter-ion (%)9.29.91
Peptide content (%w/w)96.783.72
Endotoxin (EU/mg)0.88not 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, 27 d) → laboratory (courier, cold pack, 11 d) → assay.
Assay date
03 Aug 2026
Submitted to the index
07 Aug 2026
Laboratory
VendorInvestigate, Riga, Latvia
Method basis
32 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-2607-H5219 n=16

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043027KP-2607-H5219Janoshik2026-Q396.325.9389.6Supplier-supplied3FAIL
AX-2026-043028KP-2607-H5219Janoshik2026-Q396.526.09Supplier-supplied2MARGINAL
AX-2026-043029KP-2607-H5219Medutest2026-Q395.455.71Supplier-supplied2FAIL
AX-2026-043030KP-2607-H5219Kestrel2026-Q395.976.9597.1Supplier-supplied2FAIL
AX-2026-043031KP-2607-H5219Medutest2026-Q396.285.38Buyer-sourced2FAIL
AX-2026-043032KP-2607-H5219Nordanalyt2026-Q396.695.87Supplier-supplied2MARGINAL
AX-2026-043034KP-2607-H5219Janoshik2026-Q396.135.5390.5Supplier-supplied2FAIL
AX-2026-043035KP-2607-H5219Janoshik2026-Q396.786.45106.3Supplier-supplied2MARGINAL
AX-2026-043036KP-2607-H5219Janoshik2026-Q395.675.8594.5Buyer-sourced2FAIL
AX-2026-043037KP-2607-H5219Janoshik2026-Q396.095.9695.3Supplier-supplied2FAIL
AX-2026-043038KP-2607-H5219Janoshik2026-Q396.476.07Supplier-supplied2FAIL
AX-2026-043039KP-2607-H5219Janoshik2026-Q396.145.62Supplier-supplied2FAIL
AX-2026-043040KP-2607-H5219VendorInvestigate2026-Q396.135.86Laboratory-retained2FAIL
AX-2026-043041KP-2607-H5219Kestrel2026-Q397.395.8498.9Supplier-supplied2MARGINAL
AX-2026-043042KP-2607-H5219PeptideMeter2026-Q396.115.60Buyer-sourced2FAIL
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