AssayIndex

AX-2024-004565

Retatrutide · 30 mg declared · Guangzhou JEEP Biotechnology Co., Ltd. · lot JEEP-2411-F8925

PASSVERIFIED
Report ID
AX-2024-004565
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
JEEP — Guangzhou JEEP Biotechnology Co., Ltd.
Batch / lot
JEEP-2411-F8925
Declared label claim
30mg
Laboratory
Janoshik Analytical
Assay date
07 Nov 2024
Submitted
15 Nov 2024
Quarter
2024-Q4
Submitter
r.ferreira
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 nm97.88% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks2.12% area≤ 3.5PASS
Largest single impurityRP-HPLC — C18 diacid regioisomer1.27% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula4728.4871DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4728.4961DaNOT TESTED
Mass accuracyobserved vs theoretical+1.9ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance88.17%w/wNOT TESTED
Target-compound contenttotal peptide content × purity86.30%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen35.29mg30 mg declaredNOT TESTED
Recovered target peptidegross fill × target content30.455mg30 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim101.5%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.05%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography6.57%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.21%NOT TESTED
Endotoxinkinetic chromogenic LAL0.23EU/mg≤ 5.0PASS
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite to pale-yellow 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 calibration3.912.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient20.67min20.71 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.100.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²50,933≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.59no 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.

01178235635354713 Retatrutide20.67 min · 97.88 % 21.2523.08 same trace · ×50 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 50,933, and skew follows the reported asymmetry factor of 1.10. 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 1.27 % impurity against a 97.88 % 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 peak20.674,757,27197.88
2C18 diacid regioisomer21.2561,7261.270.000
3aspartimide (−18 Da)21.3821,3850.44-18.011
4des-Aib20 analogue20.238,7490.18-85.053
5incomplete Fmoc removal (+222 Da)23.085,3460.11+222.068
6[D-Aib2]-diastereomer20.453,4020.070.000
7oxidised Trp (+16 Da)20.012,4300.05+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 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+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 4728.4961 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+676.5054676.50670.00137.8
6+789.0885789.09000.001550.3
5+946.7047946.70650.0018100.0
4+1183.12911183.13130.002253.0
3+1577.16961577.17260.00308.2
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 Fischer5.05
Counter-ion (TFA)ion chromatography6.57
Residual solvent + inorganic residueestimated0.21
Total peptide contentby difference88.17
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)97.7097.88divergence -0.17 pp vs batch median
Total impurities (% area)2.302.12
Largest single impurity (% area)not stated1.27
Water (%)3.25.05
Counter-ion (%)6.96.57
Peptide content (%w/w)89.388.17
Endotoxin (EU/mg)not stated0.23
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
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Domestic warehouse despatch → submitter (2–8 °C, 30 d) → laboratory (courier, cold pack, 2 d) → assay.
Assay date
07 Nov 2024
Submitted to the index
15 Nov 2024
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
Section 6

Annotations 2

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.

nmr_qnmr
Mass at +1.9 ppm establishes identity but not content. Absolute content needs a standard or an orthogonal quantitative method, and neither is a mass spectrometer.
mass_defect
Every named impurity on this record has a mass defect consistent with its structural assignment. That is the check that distinguishes an assignment from a guess.
Section 7

Related records

Same batch — lot JEEP-2411-F8925 n=8

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-004562JEEP-2411-F8925Janoshik2024-Q498.385.4398.2Buyer-sourced0PASS
AX-2024-004563JEEP-2411-F8925PeptideMeter2024-Q497.855.11103.0Buyer-sourced0PASS
AX-2024-004564JEEP-2411-F8925Janoshik2024-Q497.755.56Buyer-sourced0PASS
AX-2024-004566JEEP-2411-F8925PeptideMeter2024-Q497.844.82Buyer-sourced0PASS
AX-2024-004567JEEP-2411-F8925Janoshik2024-Q497.784.3291.8Buyer-sourced0PASS
AX-2024-004568JEEP-2411-F8925PeptideMeter2024-Q498.635.80Supplier-supplied0PASS
AX-2024-004569JEEP-2411-F8925Janoshik2024-Q497.926.0399.1Buyer-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 JEEP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042177HexarelinJEEP-2608-Y9547Janoshik2026-Q399.903.42Buyer-sourced0PASS
AX-2026-042162SemaglutideJEEP-2607-X9091Janoshik2026-Q398.983.46Laboratory-retained1MARGINAL
AX-2026-042127TB-500JEEP-2602-V8614Medutest2026-Q399.683.55Buyer-sourced1FAIL
AX-2026-042123TB-500JEEP-2602-V8614PeptideMeter2026-Q399.933.80Buyer-sourced0PASS
AX-2026-042124TB-500JEEP-2602-V8614PeptideMeter2026-Q399.913.37104.9Buyer-sourced0PASS
AX-2026-042178HexarelinJEEP-2608-Y9547VendorInvestigate2026-Q399.684.03Buyer-sourced0PASS
AX-2026-042163SemaglutideJEEP-2607-X9091Nordanalyt2026-Q399.464.52Buyer-sourced1MARGINAL
AX-2026-042122TB-500JEEP-2602-V8614PeptideMeter2026-Q399.603.5897.0Buyer-sourced0PASS