AssayIndex

AX-2025-019780

Retatrutide · 20 mg declared · Hubei Jianxiang Bioscience Co., Ltd. · lot HJ-2412-C3784

MARGINALVERIFIED
Report ID
AX-2025-019780
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
HJ — Hubei Jianxiang Bioscience Co., Ltd.
Batch / lot
HJ-2412-C3784
Declared label claim
20mg
Laboratory
VendorInvestigate
Assay date
13 May 2025
Submitted
26 May 2025
Quarter
2025-Q2
Submitter
g.vasquez
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 nm97.65% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks2.35% area≤ 3.5PASS
Largest single impurityRP-HPLC — incomplete Fmoc removal (+222 Da)0.93% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula4728.4871DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4728.4743DaNOT TESTED
Mass accuracyobserved vs theoretical-2.7ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance88.13%w/wNOT TESTED
Target-compound contenttotal peptide content × purity86.06%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen21.04mg20 mg declaredNOT TESTED
Recovered target peptidegross fill × target content18.107mg20 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim90.5%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate3.42%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography7.46%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.99%NOT TESTED
Endotoxinkinetic chromogenic LAL1.24EU/mg≤ 5.0PASS
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite 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 calibration3.612.5 – 8.0PASS
Retention time (observed)RP-HPLC, 32 min gradient21.93min21.98 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.240.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²65,771≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.67no 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.

01181236135424723 Retatrutide21.93 min · 97.65 % 24.5019.8821.70 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, 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 65,771, and skew follows the reported asymmetry factor of 1.24. 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 0.93 % impurity against a 97.65 % 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 peak21.934,746,09397.65
2incomplete Fmoc removal (+222 Da)24.5045,2010.93+222.068
3truncated (5-39)19.8836,4520.75-428.201
4[D-Aib2]-diastereomer21.7022,3570.460.000
5des-Aib20 analogue21.466,8040.14-85.053
6C18 diacid regioisomer22.551,9440.040.000
7aspartimide (−18 Da)22.691,4580.03-18.011
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 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 4728.4743 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+676.5054676.5036-0.00188.8
6+789.0885789.0863-0.002252.6
5+946.7047946.7021-0.0026100.0
4+1183.12911183.1259-0.003257.0
3+1577.16961577.1654-0.00429.0
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 Fischer3.42
Counter-ion (TFA)ion chromatography7.46
Residual solvent + inorganic residueestimated0.99
Total peptide contentby difference88.13
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)98.597.65divergence +0.88 pp vs batch median
Total impurities (% area)not stated2.35
Largest single impurity (% area)not stated0.93
Water (%)not stated3.42
Counter-ion (%)8.87.46
Peptide content (%w/w)87.188.13
Endotoxin (EU/mg)not stated1.24
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
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Retail purchase → third-party forwarder (5 d) → laboratory (courier, cold pack, 9 d) → assay.
Assay date
13 May 2025
Submitted to the index
26 May 2025
Laboratory
VendorInvestigate, Riga, Latvia
Method basis
32 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 HJ-2412-C3784 n=4

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-019778HJ-2412-C3784VendorInvestigate2025-Q297.404.29Buyer-sourced2MARGINAL
AX-2025-019779HJ-2412-C3784Medutest2025-Q298.124.1397.7Supplier-supplied2MARGINAL
AX-2025-019781HJ-2412-C3784Nordanalyt2025-Q297.594.2391.8Supplier-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 HJ records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042368SemaxHJ-2603-V4363Nordanalyt2026-Q399.177.26106.3Supplier-supplied1MARGINAL
AX-2026-042347SemaglutideHJ-2608-C3931VendorInvestigate2026-Q398.803.41100.2Buyer-sourced1MARGINAL
AX-2026-042367SemaxHJ-2603-V4363Kestrel2026-Q399.106.7893.9Supplier-supplied1MARGINAL
AX-2026-042348SemaglutideHJ-2608-C3931Nordanalyt2026-Q399.524.19Supplier-supplied1MARGINAL
AX-2026-042290GHRP-6HJ-2603-R2258Janoshik2026-Q399.713.05Supplier-supplied2MARGINAL
AX-2026-042287GHRP-6HJ-2603-R2258VendorInvestigate2026-Q398.792.4390.9Buyer-sourced2FAIL
AX-2026-042288GHRP-6HJ-2603-R2258Kestrel2026-Q399.932.8292.8Supplier-supplied2MARGINAL
AX-2026-042346SemaglutideHJ-2608-C3931VendorInvestigate2026-Q399.403.48Buyer-sourced1MARGINAL