AssayIndex

AX-2025-018571

Retatrutide · 12 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2412-N4087

MARGINALPURITY ONLY
Report ID
AX-2025-018571
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
WWB — Wuhan Wansheng Biotechnology Co., Ltd.
Batch / lot
WWB-2412-N4087
Declared label claim
12mg
Laboratory
Janoshik Analytical
Assay date
05 Mar 2025
Submitted
15 Mar 2025
Quarter
2025-Q1
Submitter
csv_parser
Sample provenance
Laboratory-retained
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 nm99.19% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.81% area≤ 3.5PASS
Largest single impurityRP-HPLC — truncated (5-39)0.48% 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, duplicate3.57%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography9.90%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.38%NOT TESTED
Endotoxinkinetic chromogenic LAL0.27EU/mg≤ 5.0PASS
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 calibration4.902.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient20.71min20.71 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.080.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²63,897≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.65no 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.

01348269540435390 Retatrutide20.71 min · 99.19 % 18.7920.4924.83 same trace · ×100 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 63,897, and skew follows the reported asymmetry factor of 1.08. 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 0.48 % impurity against a 99.19 % 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 peak20.714,820,94199.19
2truncated (5-39)18.7923,3290.48-428.201
3[D-Aib2]-diastereomer20.496,8040.140.000
4retatrutide dimer24.834,3740.09+4728.487
5aspartimide (−18 Da)21.422,9160.06-18.011
6oxidised Trp (+16 Da)20.051,9440.04+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 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)99.9099.19divergence +0.64 pp vs batch median
Total impurities (% area)0.100.81
Largest single impurity (% area)not stated0.48
Water (%)1.53.57
Counter-ion (%)not stated9.90
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)0.210.27
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
Laboratory-retained
Evidentiary weight
Provenance documented, selection uncontrolled.
Chain of custody
Laboratory retained sample (−20 °C, 16 d since original receipt) → re-assay.
Assay date
05 Mar 2025
Submitted to the index
15 Mar 2025
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 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-2412-N4087 n=10

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-018563WWB-2412-N4087Medutest2025-Q199.173.74101.3Supplier-supplied1MARGINAL
AX-2025-018564WWB-2412-N4087PeptideMeter2025-Q199.323.57Supplier-supplied1MARGINAL
AX-2025-018565WWB-2412-N4087Janoshik2025-Q199.123.0794.1Supplier-supplied1MARGINAL
AX-2025-018566WWB-2412-N4087Janoshik2025-Q199.933.3891.6Supplier-supplied1MARGINAL
AX-2025-018567WWB-2412-N4087Janoshik2025-Q199.163.64Supplier-supplied1MARGINAL
AX-2025-018568WWB-2412-N4087Kestrel2025-Q199.863.25Supplier-supplied2FAIL
AX-2025-018569WWB-2412-N4087Janoshik2025-Q199.763.00Supplier-supplied1MARGINAL
AX-2025-018570WWB-2412-N4087Janoshik2025-Q199.153.36Supplier-supplied1MARGINAL
AX-2025-018572WWB-2412-N4087Janoshik2025-Q199.933.6691.6Supplier-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