AssayIndex

AX-2026-043129

Retatrutide · 5 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2510-E6613

MARGINALPURITY ONLY
Report ID
AX-2026-043129
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Batch / lot
SSA-2510-E6613
Declared label claim
5mg
Laboratory
Medutest
Assay date
26 Dec 2025
Submitted
16 Jan 2026
Quarter
2025-Q4
Submitter
n.petrescu
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, 25 min gradient, 214 nm97.41% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks2.59% area≤ 3.5PASS
Largest single impurityRP-HPLC — [D-Aib2]-diastereomer1.38% area≤ 1.00FAIL
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, duplicate4.69%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography7.70%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.20%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 backgroundWhite cake, partial shrinkage from vial wallwhite to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureVisible particulates, did not clearclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.922.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient16.90min17.53 ± 0.50 (normalised)FAIL
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.080.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²52,616≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.61no 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.

01473294644195892 Retatrutide16.90 min · 97.41 % 16.7218.91 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0481216202428 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 25 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 52,616, 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 1.38 % impurity against a 97.41 % 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 peak16.904,734,42897.41
2[D-Aib2]-diastereomer16.7267,0721.380.000
3des-Aib20 analogue16.5334,5080.71-85.053
4oxidised Trp (+16 Da)16.3514,5810.30+15.995
5incomplete Fmoc removal (+222 Da)18.916,3180.13+222.068
6retatrutide dimer20.331,9440.04+4728.487
7aspartimide (−18 Da)17.491,4580.03-18.011
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)97.597.41divergence +0.14 pp vs batch median
Total impurities (% area)2.502.59
Largest single impurity (% area)not stated1.38
Water (%)2.94.69
Counter-ion (%)7.37.70
Peptide content (%w/w)89.2not determined
Endotoxin (EU/mg)not statednot determined
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, 9 d) → assay. Submitter did not handle the vial.
Assay date
26 Dec 2025
Submitted to the index
16 Jan 2026
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-resolution MS
Verification status
PURITY ONLY
Section 6

Annotations 3

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.

buyer_sourced
Blind purchase through an ordinary retail channel is the provenance class this index weights. Nothing prevents anyone from generating one for SSA-2510-E6613; it costs the price of a vial.
aib_two
On the multi-Aib analogues the des-Aib species elutes a third of a minute early and routinely arrives as a leading shoulder rather than a peak. That is a compound property and every laboratory faces it.
c18_2p6
Doubling column length gains 40 % resolution and doubles the run. On a routine release method that trade is usually declined, and the certificate should say which method was run.
Section 7

Related records

Same batch — lot SSA-2510-E6613 n=11

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020552SSA-2510-E6613Janoshik2025-Q497.364.26Buyer-sourced1MARGINAL
AX-2025-020553SSA-2510-E6613VendorInvestigate2025-Q496.873.72Buyer-sourced1MARGINAL
AX-2025-020554SSA-2510-E6613Janoshik2025-Q497.123.97Buyer-sourced1MARGINAL
AX-2025-020555SSA-2510-E6613Medutest2025-Q496.764.4593.3Buyer-sourced1MARGINAL
AX-2025-020556SSA-2510-E6613Janoshik2025-Q497.724.11105.2Supplier-supplied1MARGINAL
AX-2025-020557SSA-2510-E6613Medutest2025-Q497.844.6194.0Supplier-supplied1MARGINAL
AX-2025-020558SSA-2510-E6613Nordanalyt2025-Q497.033.97Supplier-supplied1MARGINAL
AX-2025-020559SSA-2510-E6613Janoshik2025-Q497.764.01104.8Supplier-supplied1MARGINAL
AX-2025-020560SSA-2510-E6613Janoshik2025-Q497.363.94Supplier-supplied1MARGINAL
AX-2025-020561SSA-2510-E6613VendorInvestigate2025-Q496.904.1093.2Buyer-sourced1MARGINAL
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 SSA records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043135BPC-157SSA-2601-N6863Nordanalyt2026-Q298.164.6692.8Buyer-sourced1MARGINAL
AX-2026-043160GHK-CuSSA-2604-V7731Janoshik2026-Q298.014.0291.8Buyer-sourced0PASS
AX-2026-043157GHK-CuSSA-2604-V7731Medutest2026-Q299.195.14Supplier-supplied0PASS
AX-2026-043141BPC-157SSA-2601-N6863Janoshik2026-Q298.064.0694.6Buyer-sourced1MARGINAL
AX-2026-043154GHK-CuSSA-2604-V7731PeptideMeter2026-Q297.824.82101.6Buyer-sourced0PASS
AX-2026-043137BPC-157SSA-2601-N6863PeptideMeter2026-Q298.174.14Buyer-sourced1MARGINAL
AX-2026-043162GHK-CuSSA-2604-V7731Janoshik2026-Q298.504.36Supplier-supplied0PASS
AX-2026-043134BPC-157SSA-2601-N6863Medutest2026-Q297.894.01Buyer-sourced1FAIL