AssayIndex

AX-2026-041592

Retatrutide · 12 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2510-H7626

MARGINALVERIFIED
Report ID
AX-2026-041592
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
QSC — Qingdao Sigma Chemical Co., Ltd.
Batch / lot
QSC-2510-H7626
Declared label claim
12mg
Laboratory
Janoshik Analytical
Assay date
14 Feb 2026
Submitted
02 Mar 2026
Quarter
2026-Q1
Submitter
k.fontaine
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 nm97.90% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks2.10% area≤ 3.5PASS
Largest single impurityRP-HPLC — des-Aib20 analogue1.19% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula4728.4871DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4728.4800DaNOT TESTED
Mass accuracyobserved vs theoretical-1.5ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance87.77%w/wNOT TESTED
Target-compound contenttotal peptide content × purity85.93%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen12.95mg12 mg declaredNOT TESTED
Recovered target peptidegross fill × target content11.128mg12 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim92.7%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate3.29%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography7.97%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.97%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 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 calibration4.012.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient20.75min20.71 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.910.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²63,106≥ 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.

01437287343105747 Retatrutide20.75 min · 97.90 % 20.3123.16 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 63,106, and skew follows the reported asymmetry factor of 0.91. 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 1.19 % impurity against a 97.90 % 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 peak20.754,758,24397.90
2des-Aib20 analogue20.3157,8381.19-85.053
3[D-Aib2]-diastereomer20.5329,6480.610.000
4C18 diacid regioisomer21.337,7760.160.000
5truncated (5-39)18.833,8880.08-428.201
6incomplete Fmoc removal (+222 Da)23.161,9440.04+222.068
7aspartimide (−18 Da)21.469720.02-18.011
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 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 4728.4800 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+676.5054676.5044-0.00108.7
6+789.0885789.0873-0.001253.3
5+946.7047946.7033-0.0014100.0
4+1183.12911183.1273-0.001857.2
3+1577.16961577.1673-0.00237.9
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 Fischer3.29
Counter-ion (TFA)ion chromatography7.97
Residual solvent + inorganic residueestimated0.97
Total peptide contentby difference87.77
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)99.097.90divergence +1.10 pp vs batch median
Total impurities (% area)not stated2.10
Largest single impurity (% area)not stated1.19
Water (%)not stated3.29
Counter-ion (%)not stated7.97
Peptide content (%w/w)91.787.77
Endotoxin (EU/mg)1.72not 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
Laboratory-retained
Evidentiary weight
Provenance documented, selection uncontrolled.
Chain of custody
Laboratory retained sample (−20 °C, 8 d since original receipt) → re-assay.
Assay date
14 Feb 2026
Submitted to the index
02 Mar 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
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 QSC-2510-H7626 n=3

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041593QSC-2510-H7626Nordanalyt2026-Q197.734.1794.9Supplier-supplied2MARGINAL
AX-2026-041594QSC-2510-H7626Janoshik2026-Q198.423.63Supplier-supplied2MARGINAL
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 QSC records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041683CJC-1295 (no DAC)QSC-2606-V8637Janoshik2026-Q399.933.6397.1Supplier-supplied1FAIL
AX-2026-041727CJC-1295 with DACQSC-2602-E9474Janoshik2026-Q398.886.62105.3Supplier-supplied1MARGINAL
AX-2026-041728CJC-1295 with DACQSC-2602-E9474VendorInvestigate2026-Q398.427.04Buyer-sourced1MARGINAL
AX-2026-041734CJC-1295 with DACQSC-2602-E9474Medutest2026-Q399.437.17105.5Supplier-supplied2FAIL
AX-2026-041652LiraglutideQSC-2605-W8602Nordanalyt2026-Q399.336.55Supplier-supplied0PASS
AX-2026-041730CJC-1295 with DACQSC-2602-E9474PeptideMeter2026-Q398.796.9395.4Supplier-supplied1MARGINAL
AX-2026-041686CJC-1295 (no DAC)QSC-2606-V8637Janoshik2026-Q399.934.04Supplier-supplied0PASS
AX-2026-041653LiraglutideQSC-2605-W8602VendorInvestigate2026-Q398.825.95Buyer-sourced0PASS