AssayIndex

AX-2026-042978

Retatrutide · 10 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2511-K4263

MARGINALIDENTITY CONSISTENT
Report ID
AX-2026-042978
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot
KP-2511-K4263
Declared label claim
10mg
Laboratory
Nordanalyt Laboratories
Assay date
07 Mar 2026
Submitted
09 Mar 2026
Quarter
2026-Q1
Submitter
i.trevino
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, 35 min gradient, 214 nm97.67% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks2.33% area≤ 3.5PASS
Largest single impurityRP-HPLC — incomplete Fmoc removal (+222 Da)1.54% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula4728.4871DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4728.4729DaNOT TESTED
Mass accuracyobserved vs theoretical-3.0ppm± 15PASS
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate3.30%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography9.20%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/1.00%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 with a single visible fibreclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.942.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient23.99min23.89 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.520.80 – 1.50FAIL
Plate count, main peakN = 5.54 (t/w½)²56,393≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.62no 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.

0888177726653554 Retatrutide23.99 min · 97.67 % 26.8021.7524.8228.80 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0510152025303540 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 35 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 56,393, and skew follows the reported asymmetry factor of 1.52. 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 1.54 % impurity against a 97.67 % 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 peak23.994,747,06597.67
2incomplete Fmoc removal (+222 Da)26.8074,8491.54+222.068
3aspartimide (−18 Da)24.8216,0390.33-18.011
4truncated (5-39)21.7515,0670.31-428.201
5[D-Aib2]-diastereomer23.734,3740.090.000
6des-Aib20 analogue23.481,4580.03-85.053
7retatrutide dimer28.801,4580.03+4728.487
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 4728.4729 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+676.5054676.5034-0.00208.6
6+789.0885789.0861-0.002452.6
5+946.7047946.7019-0.0028100.0
4+1183.12911183.1255-0.003656.5
3+1577.16961577.1649-0.00478.3
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.

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)97.4697.67divergence +0.34 pp vs batch median
Total impurities (% area)not stated2.33
Largest single impurity (% area)not stated1.54
Water (%)not stated3.30
Counter-ion (%)not stated9.20
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)0.35not determined
Method stated on certificateNOno method section — the result cannot be reconciled against any other
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, 6 d) → assay. Submitter did not handle the vial.
Assay date
07 Mar 2026
Submitted to the index
09 Mar 2026
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 min gradient · high-resolution MS
Verification status
IDENTITY CONSISTENT
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-2511-K4263 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042972KP-2511-K4263Janoshik2026-Q196.653.75107.2Supplier-supplied2MARGINAL
AX-2026-042973KP-2511-K4263Nordanalyt2026-Q197.083.64105.1Supplier-supplied2MARGINAL
AX-2026-042974KP-2511-K4263Janoshik2026-Q197.053.6399.2Buyer-sourced2MARGINAL
AX-2026-042975KP-2511-K4263Janoshik2026-Q196.713.3792.7Supplier-supplied2MARGINAL
AX-2026-042976KP-2511-K4263Medutest2026-Q197.253.5198.9Supplier-supplied2MARGINAL
AX-2026-042977KP-2511-K4263Janoshik2026-Q197.123.55106.1Supplier-supplied2MARGINAL
AX-2026-042979KP-2511-K4263Medutest2026-Q197.283.9798.5Supplier-supplied2MARGINAL
AX-2026-042980KP-2511-K4263Janoshik2026-Q197.234.39Supplier-supplied2MARGINAL
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