AssayIndex

AX-2024-004152

Retatrutide · 30 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2408-X2078

MARGINALPURITY ONLY
Report ID
AX-2024-004152
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
WWB — Wuhan Wansheng Biotechnology Co., Ltd.
Batch / lot
WWB-2408-X2078
Declared label claim
30mg
Laboratory
PeptideMeter
Assay date
06 Oct 2024
Submitted
26 Oct 2024
Quarter
2024-Q4
Submitter
m.danquah
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, 28 min gradient, 214 nm99.37% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.63% area≤ 3.5PASS
Largest single impurityRP-HPLC — oxidised Trp (+16 Da)0.38% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate5.69%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography7.87%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.51%NOT TESTED
Endotoxinkinetic chromogenic LAL1.29EU/mg≤ 5.0PASS
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, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.812.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient19.61min19.44 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.280.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²40,992≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.52no 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.

01042208431264168 Retatrutide19.61 min · 99.37 % 18.9921.86 same trace · ×100 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 051015202530 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 28 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 40,992, and skew follows the reported asymmetry factor of 1.28. 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 0.38 % impurity against a 99.37 % 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 peak19.614,829,69099.37
2oxidised Trp (+16 Da)18.9918,4690.38+15.995
3aspartimide (−18 Da)20.277,2900.15-18.011
4[D-Aib2]-diastereomer19.402,4300.050.000
5truncated (5-39)17.821,4580.03-428.201
6incomplete Fmoc removal (+222 Da)21.869720.02+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 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)99.9099.37divergence +1.02 pp vs batch median
Total impurities (% area)0.100.63
Largest single impurity (% area)0.040.38
Water (%)3.85.69
Counter-ion (%)5.17.87
Peptide content (%w/w)90.5not determined
Endotoxin (EU/mg)1.061.29
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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 2 d) → assay. Submitter did not handle the vial.
Assay date
06 Oct 2024
Submitted to the index
26 Oct 2024
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 min gradient · high-resolution MS
Verification status
PURITY ONLY
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 WWB-2408-X2078 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-004144WWB-2408-X2078VendorInvestigate2024-Q499.195.93105.9Buyer-sourced1MARGINAL
AX-2024-004145WWB-2408-X2078Janoshik2024-Q498.886.3090.4Supplier-supplied1MARGINAL
AX-2024-004146WWB-2408-X2078Janoshik2024-Q498.845.81Supplier-supplied1MARGINAL
AX-2024-004147WWB-2408-X2078PeptideMeter2024-Q499.455.7389.0Supplier-supplied1MARGINAL
AX-2024-004148WWB-2408-X2078Nordanalyt2024-Q499.385.4389.8Supplier-supplied2MARGINAL
AX-2024-004149WWB-2408-X2078Medutest2024-Q498.646.43Supplier-supplied1MARGINAL
AX-2024-004150WWB-2408-X2078Janoshik2024-Q498.775.71Supplier-supplied1MARGINAL
AX-2024-004151WWB-2408-X2078Janoshik2024-Q498.686.7095.1Supplier-supplied1MARGINAL
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 WWB records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041275LiraglutideWWB-2607-X2189Nordanalyt2026-Q399.615.0397.3Supplier-supplied0PASS
AX-2026-041387BPC-157WWB-2606-H3906Janoshik2026-Q398.954.64Laboratory-retained1MARGINAL
AX-2026-041334SemaglutideWWB-2606-N3192Janoshik2026-Q398.835.04Supplier-supplied1MARGINAL
AX-2026-041337SemaglutideWWB-2606-N3192Nordanalyt2026-Q398.964.81Supplier-supplied1MARGINAL
AX-2026-041385BPC-157WWB-2606-H3906Medutest2026-Q399.314.31Supplier-supplied1MARGINAL
AX-2026-041390BPC-157WWB-2606-H3906Medutest2026-Q399.474.8499.3Supplier-supplied1MARGINAL
AX-2026-041386BPC-157WWB-2606-H3906VendorInvestigate2026-Q399.324.8899.2Buyer-sourced1MARGINAL
AX-2026-041335SemaglutideWWB-2606-N3192Janoshik2026-Q399.554.55100.5Supplier-supplied1MARGINAL