AssayIndex

AX-2024-004661

Retatrutide · 15 mg declared · Tianjin Finder Chemical Co., Ltd. · lot TFC-2309-H2397

PASSVERIFIED
Report ID
AX-2024-004661
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
TFC — Tianjin Finder Chemical Co., Ltd.
Batch / lot
TFC-2309-H2397
Declared label claim
15mg
Laboratory
VendorInvestigate
Assay date
31 Jan 2024
Submitted
14 Feb 2024
Quarter
2024-Q1
Submitter
g.petrov
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, 32 min gradient, 214 nm98.50% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.50% area≤ 3.5PASS
Largest single impurityRP-HPLC — [D-Aib2]-diastereomer0.67% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula4728.4871Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4728.4937Da—NOT TESTED
Mass accuracyobserved vs theoretical+1.4ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance86.21%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity84.92%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen17.01mg15 mg declaredNOT TESTED
Recovered target peptidegross fill × target content14.445mg15 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim96.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.34%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography8.60%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.85%—NOT TESTED
Endotoxinkinetic chromogenic LAL1.52EU/mg≤ 5.0PASS
Sterilitynot ordered on this submissionnot determined—no growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite cake, partial shrinkage from vial wall—white to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.62—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 32 min gradient22.08min21.98 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.23—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²67,310—≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.67—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.

01202240436074809 Retatrutide22.08 min · 98.50 % 21.8520.0326.47 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, 32 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 67,310, and skew follows the reported asymmetry factor of 1.23. 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 0.67 % impurity against a 98.50 % 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 peak22.084,787,40598.50—
2[D-Aib2]-diastereomer21.8532,5640.670.000
3truncated (5-39)20.0321,3850.44-428.201
4des-Aib20 analogue21.619,7210.20-85.053
5retatrutide dimer26.475,3460.11+4728.487
6oxidised Trp (+16 Da)21.382,9160.06+15.995
7C18 diacid regioisomer22.709720.020.000
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+946.71[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 4728.4937 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+676.5054676.50640.00108.2
6+789.0885789.08960.001156.5
5+946.7047946.70600.0013100.0
4+1183.12911183.13070.001657.7
3+1577.16961577.17180.00227.8
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 Fischer4.34
Counter-ion (TFA)ion chromatography8.60
Residual solvent + inorganic residueestimated0.85
Total peptide contentby difference86.21
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)99.9098.50divergence +1.27 pp vs batch median
Total impurities (% area)0.101.50
Largest single impurity (% area)0.070.67
Water (%)2.44.34
Counter-ion (%)2.68.60
Peptide content (%w/w)94.486.21
Endotoxin (EU/mg)not stated1.52
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
Retail purchase → submitter (−20 °C, 16 d) → laboratory (courier, dry ice, 11 d) → assay.
Assay date
31 Jan 2024
Submitted to the index
14 Feb 2024
Laboratory
VendorInvestigate, Riga, Latvia
Method basis
32 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.

chain_custody
Custody from checkout to injection is documented on this record. Provenance plus custody is what makes a single result generalise past the vial it came from.
storage_stated
Stated storage conditions on the certificate against the observed transit conditions in the custody block: on this record they agree, which removes one class of explanation for anything unexpected.
Section 7

Related records

Same batch — lot TFC-2309-H2397 n=17

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-004645TFC-2309-H2397Janoshik2024-Q198.533.7090.7Buyer-sourced0PASS
AX-2024-004646TFC-2309-H2397Nordanalyt2024-Q198.674.32102.6Buyer-sourced2FAIL
AX-2024-004647TFC-2309-H2397Nordanalyt2024-Q198.504.42—Supplier-supplied0PASS
AX-2024-004648TFC-2309-H2397PeptideMeter2024-Q198.664.06104.9Buyer-sourced0PASS
AX-2024-004649TFC-2309-H2397PeptideMeter2024-Q198.793.64—Buyer-sourced0PASS
AX-2024-004650TFC-2309-H2397Medutest2024-Q198.743.93100.4Buyer-sourced1MARGINAL
AX-2024-004651TFC-2309-H2397Janoshik2024-Q198.863.9099.4Buyer-sourced0PASS
AX-2024-004652TFC-2309-H2397PeptideMeter2024-Q198.634.14—Buyer-sourced0PASS
AX-2024-004653TFC-2309-H2397Medutest2024-Q198.293.41—Laboratory-retained0PASS
AX-2024-004654TFC-2309-H2397Janoshik2024-Q198.484.64100.7Buyer-sourced0PASS
AX-2024-004655TFC-2309-H2397VendorInvestigate2024-Q198.433.6493.7Buyer-sourced0PASS
AX-2024-004656TFC-2309-H2397Janoshik2024-Q198.494.83—Buyer-sourced1FAIL
AX-2024-004657TFC-2309-H2397PeptideMeter2024-Q198.674.27—Buyer-sourced0PASS
AX-2024-004658TFC-2309-H2397PeptideMeter2024-Q198.704.31105.7Buyer-sourced0PASS
AX-2024-004659TFC-2309-H2397Medutest2024-Q198.363.87—Buyer-sourced0PASS
AX-2024-004660TFC-2309-H2397Medutest2024-Q198.763.96105.4Buyer-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 TFC records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042265Humanin (HNG)TFC-2605-U1300PeptideMeter2026-Q399.526.31—Buyer-sourced0PASS
AX-2026-042222SS-31 (Elamipretide)TFC-2607-R9099VendorInvestigate2026-Q399.465.41102.6Buyer-sourced0PASS
AX-2026-042236Humanin (HNG)TFC-2608-S9940Nordanalyt2026-Q398.641.80—Buyer-sourced0PASS
AX-2026-042282RetatrutideTFC-2608-J1156Janoshik2026-Q398.544.27—Buyer-sourced0PASS
AX-2026-042226SS-31 (Elamipretide)TFC-2607-R9099Janoshik2026-Q399.625.47—Buyer-sourced0PASS
AX-2026-042217SemaglutideTFC-2604-X9037PeptideMeter2026-Q398.954.6196.9Buyer-sourced0PASS
AX-2026-042339SermorelinTFC-2605-Y2176Kestrel2026-Q399.934.14—Supplier-supplied1FAIL
AX-2026-042214SemaglutideTFC-2604-X9037Kestrel2026-Q399.874.66103.1Laboratory-retained0PASS