AssayIndex

AX-2024-004312

Retatrutide · 12 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2408-X7558

PASSVERIFIED
Report ID
AX-2024-004312
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
QSC — Qingdao Sigma Chemical Co., Ltd.
Batch / lot
QSC-2408-X7558
Declared label claim
12mg
Laboratory
Janoshik Analytical
Assay date
17 Oct 2024
Submitted
10 Nov 2024
Quarter
2024-Q4
Submitter
m.ostergaard
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 nm99.04% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.96% area≤ 3.5PASS
Largest single impurityRP-HPLC — [D-Aib2]-diastereomer0.53% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula4728.4871Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4728.4658Da—NOT TESTED
Mass accuracyobserved vs theoretical-4.5ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance88.33%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity87.48%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen12.96mg12 mg declaredNOT TESTED
Recovered target peptidegross fill × target content11.337mg12 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim94.5%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.10%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography6.05%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.52%—NOT TESTED
Endotoxinkinetic chromogenic LAL0.98EU/mg≤ 5.0PASS
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 d—no growthPASS
Appearancevisual, diffuse light, black and white backgroundOff-white lyophilised cake, intact—white to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureFaint haze, clearing on standing—clear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.76—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient20.55min20.71 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.33—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²41,233—≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.53—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.

0974194729213895 Retatrutide20.55 min · 99.04 % 20.3322.9618.63 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 41,233, and skew follows the reported asymmetry factor of 1.33. 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 0.53 % impurity against a 99.04 % 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 peak20.554,813,65199.04—
2[D-Aib2]-diastereomer20.3325,7600.530.000
3incomplete Fmoc removal (+222 Da)22.9611,1790.23+222.068
4C18 diacid regioisomer21.136,8040.140.000
5truncated (5-39)18.631,9440.04-428.201
6aspartimide (−18 Da)21.269720.02-18.011
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+1183.12[M+6H]6+789.08 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 4728.4658 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+676.5054676.5024-0.00309.1
6+789.0885789.0849-0.003654.5
5+946.7047946.7004-0.0043100.0
4+1183.12911183.1237-0.005458.1
3+1577.16961577.1625-0.00718.2
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 Fischer5.10
Counter-ion (TFA)ion chromatography6.05
Residual solvent + inorganic residueestimated0.52
Total peptide contentby difference88.33
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)99.0199.04divergence +0.11 pp vs batch median
Total impurities (% area)0.990.96
Largest single impurity (% area)0.720.53
Water (%)not stated5.10
Counter-ion (%)not stated6.05
Peptide content (%w/w)91.788.33
Endotoxin (EU/mg)not stated0.98
Method stated on certificateYES—column, 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
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Domestic warehouse despatch → submitter (2–8 °C, 19 d) → laboratory (courier, cold pack, 5 d) → assay.
Assay date
17 Oct 2024
Submitted to the index
10 Nov 2024
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.

quad_unit
Instrument class is on the record, which is what allows -4.5 ppm to be read at its proper weight. The index distinguishes "confirmed" from "consistent with" precisely on this field.
esi_tof
The observed monoisotopic mass on this record reconciles with the theoretical value to four decimal places, which is the arithmetic the index re-derives in its own build check rather than accepting from the report.
Section 7

Related records

Same batch — lot QSC-2408-X7558 n=6

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-004310QSC-2408-X7558Kestrel2024-Q499.365.55102.2Buyer-sourced0PASS
AX-2024-004311QSC-2408-X7558Janoshik2024-Q498.955.75104.0Buyer-sourced1FAIL
AX-2025-018732QSC-2408-X7558Janoshik2024-Q498.565.82—Buyer-sourced0PASS
AX-2024-004313QSC-2408-X7558Nordanalyt2024-Q498.854.8997.7Buyer-sourced0PASS
AX-2024-004314QSC-2408-X7558PeptideMeter2024-Q498.185.3790.4Buyer-sourced0PASS

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 QSC records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041599CJC-1295 (no DAC)QSC-2606-V7416VendorInvestigate2026-Q397.963.52—Buyer-sourced1FAIL
AX-2026-041601CJC-1295 (no DAC)QSC-2606-V7416Kestrel2026-Q398.334.10—Buyer-sourced1MARGINAL
AX-2026-041602CJC-1295 (no DAC)QSC-2606-V7416VendorInvestigate2026-Q398.363.38101.8Buyer-sourced1MARGINAL
AX-2026-041477TriptorelinQSC-2607-C5749Nordanalyt2026-Q399.533.42—Buyer-sourced0PASS
AX-2026-041600CJC-1295 (no DAC)QSC-2606-V7416Nordanalyt2026-Q397.744.91100.9Buyer-sourced1FAIL
AX-2026-041603CJC-1295 (no DAC)QSC-2606-V7416PeptideMeter2026-Q398.434.20—Buyer-sourced1MARGINAL
AX-2026-041606CJC-1295 (no DAC)QSC-2606-V7416Janoshik2026-Q398.033.58—Buyer-sourced1MARGINAL
AX-2026-041585LiraglutideQSC-2605-W7381Medutest2026-Q399.595.0992.8Laboratory-retained0PASS