AssayIndex

AX-2025-020050

Retatrutide · 15 mg declared · Shanghai Wibson Biotechnology Co., Ltd. · lot SWB-2503-P7565

MARGINALVERIFIED
Report ID
AX-2025-020050
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
SWB — Shanghai Wibson Biotechnology Co., Ltd.
Batch / lot
SWB-2503-P7565
Declared label claim
15mg
Laboratory
Janoshik Analytical
Assay date
22 Apr 2025
Submitted
06 May 2025
Quarter
2025-Q2
Submitter
z.mensa
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 nm98.17% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.83% area≤ 3.5PASS
Largest single impurityRP-HPLC — [D-Aib2]-diastereomer0.89% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula4728.4871Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4728.4866Da—NOT TESTED
Mass accuracyobserved vs theoretical-0.1ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance84.05%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity82.51%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen18.16mg15 mg declaredNOT TESTED
Recovered target peptidegross fill × target content14.984mg15 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim99.9%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.97%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography10.01%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.97%—NOT TESTED
Endotoxinnot ordered on this submissionnot determined—≤ 5.0NOT TESTED
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 d—no growthPASS
Appearancevisual, diffuse light, black and white backgroundWhite to pale-yellow cake, intact—white to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.83—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient20.77min20.71 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.18—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²79,984—≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.73—no 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.

01420284042605680 Retatrutide20.77 min · 98.17 % 20.5523.1818.8524.89 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 79,984, and skew follows the reported asymmetry factor of 1.18. 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 0.89 % impurity against a 98.17 % 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 peak20.774,771,36698.17—
2[D-Aib2]-diastereomer20.5543,2570.890.000
3des-Aib20 analogue20.3324,7880.51-85.053
4C18 diacid regioisomer21.359,7210.200.000
5incomplete Fmoc removal (+222 Da)23.185,8320.12+222.068
6retatrutide dimer24.892,9160.06+4728.487
7truncated (5-39)18.852,4300.05-428.201
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 4728.4866 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+676.5054676.5054-0.00008.5
6+789.0885789.0884-0.000150.5
5+946.7047946.7046-0.0001100.0
4+1183.12911183.1289-0.000251.0
3+1577.16961577.1695-0.00018.6
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 Fischer4.97
Counter-ion (TFA)ion chromatography10.01
Residual solvent + inorganic residueestimated0.97
Total peptide contentby difference84.05
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)99.098.17divergence +0.46 pp vs batch median
Total impurities (% area)1.001.83
Largest single impurity (% area)not stated0.89
Water (%)2.64.97
Counter-ion (%)not stated10.01
Peptide content (%w/w)92.684.05
Endotoxin (EU/mg)not statednot determined
Method stated on certificateNO—no 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
Retail purchase → third-party forwarder (33 d) → laboratory (courier, cold pack, 10 d) → assay.
Assay date
22 Apr 2025
Submitted to the index
06 May 2025
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.

tbu_residual
No +56 Da satellite in the envelope, which is the residual-protection signature. Its absence is worth as much as the parent mass being right.
schema_v2
Both the theoretical and the observed monoisotopic mass are in the published dataset, so the ppm figure can be re-derived rather than trusted. That is the intent of publishing both.
Section 7

Related records

Same batch — lot SWB-2503-P7565 n=11

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020051SWB-2503-P7565Kestrel2025-Q299.414.90—Supplier-supplied2MARGINAL
AX-2025-020052SWB-2503-P7565PeptideMeter2025-Q298.765.0493.9Buyer-sourced1MARGINAL
AX-2025-020053SWB-2503-P7565Kestrel2025-Q298.654.9989.6Buyer-sourced2MARGINAL
AX-2025-020054SWB-2503-P7565PeptideMeter2025-Q298.154.69—Buyer-sourced1MARGINAL
AX-2025-020055SWB-2503-P7565Medutest2025-Q298.324.91—Buyer-sourced1MARGINAL
AX-2025-020056SWB-2503-P7565PeptideMeter2025-Q298.534.94—Buyer-sourced1MARGINAL
AX-2025-020057SWB-2503-P7565Kestrel2025-Q298.824.99—Buyer-sourced2FAIL
AX-2025-020058SWB-2503-P7565Medutest2025-Q298.755.08—Buyer-sourced1MARGINAL
AX-2025-020059SWB-2503-P7565PeptideMeter2025-Q297.955.1894.3Buyer-sourced1MARGINAL
AX-2025-020060SWB-2503-P7565Janoshik2025-Q298.544.52—Buyer-sourced1MARGINAL

Cross-sections

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-Q398.544.27—Buyer-sourced0PASS
AX-2026-043094KPKP-2607-H5774PeptideMeter2026-Q396.326.40—Buyer-sourced0FAIL
AX-2026-042441HomopeptideHOMO-2605-V4718Medutest2026-Q398.934.22—Buyer-sourced0PASS
AX-2026-041427QYBQYB-2604-B4920PeptideMeter2026-Q397.932.45101.7Buyer-sourced0PASS
AX-2026-041786ASYASY-{CAT}-2288VendorInvestigate2026-Q398.786.59—Buyer-sourced0PASS
AX-2026-041428QYBQYB-2604-B4920Janoshik2026-Q398.353.20—Laboratory-retained0PASS
Other recent SWB records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042637SemaglutideSWB-2602-X7905Janoshik2026-Q398.374.26102.9Buyer-sourced0PASS
AX-2026-042645SemaglutideSWB-2602-X7905Medutest2026-Q398.484.5295.2Buyer-sourced0PASS
AX-2026-042642SemaglutideSWB-2602-X7905PeptideMeter2026-Q397.964.4890.8Buyer-sourced0PASS
AX-2026-042640SemaglutideSWB-2602-X7905PeptideMeter2026-Q398.554.29—Buyer-sourced0PASS
AX-2026-042638SemaglutideSWB-2602-X7905Janoshik2026-Q398.743.65—Buyer-sourced0PASS
AX-2026-042639SemaglutideSWB-2602-X7905Janoshik2026-Q398.774.21—Supplier-supplied0PASS
AX-2026-042641SemaglutideSWB-2602-X7905Janoshik2026-Q398.864.4899.1Buyer-sourced0PASS
AX-2026-042644SemaglutideSWB-2602-X7905PeptideMeter2026-Q398.763.5797.7Buyer-sourced0PASS