AssayIndex

AX-2025-020239

Retatrutide · 12 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2508-E1731

MARGINALPURITY ONLY
Report ID
AX-2025-020239
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
GGPeps — Nantong Guangyuan Chemical Co., Ltd.
Batch / lot
GGPE-2508-E1731
Declared label claim
12mg
Laboratory
Medutest
Assay date
05 Sep 2025
Submitted
21 Sep 2025
Quarter
2025-Q3
Submitter
s.ndiaye
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, 25 min gradient, 214 nm97.93% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks2.07% area≤ 3.5PASS
Largest single impurityRP-HPLC — des-Aib20 analogue0.87% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance89.08%w/wNOT TESTED
Target-compound contenttotal peptide content × purity87.24%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen12.22mg12 mg declaredNOT TESTED
Recovered target peptidegross fill × target content10.661mg12 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim88.8%90.0 – 110.0FAIL
Water contentKarl Fischer, coulometric, duplicate2.18%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography7.91%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.83%NOT TESTED
Endotoxinkinetic chromogenic LAL0.43EU/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 calibration4.202.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient17.18min17.53 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.320.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²59,263≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.63no 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.

01385277041555540 Retatrutide17.18 min · 97.93 % 16.8120.61 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 59,263, and skew follows the reported asymmetry factor of 1.32. 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 0.87 % impurity against a 97.93 % 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 peak17.184,759,70297.93
2des-Aib20 analogue16.8142,2850.87-85.053
3retatrutide dimer20.6137,4240.77+4728.487
4incomplete Fmoc removal (+222 Da)19.1910,2070.21+222.068
5[D-Aib2]-diastereomer17.007,2900.150.000
6C18 diacid regioisomer17.661,9440.040.000
7oxidised Trp (+16 Da)16.631,4580.03+15.995
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.

ComponentDetermination%w/w of cake
WaterKarl Fischer2.18
Counter-ion (TFA)ion chromatography7.91
Residual solvent + inorganic residueestimated0.83
Total peptide contentby difference89.08
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)98.0297.93divergence +0.04 pp vs batch median
Total impurities (% area)1.982.07
Largest single impurity (% area)1.460.87
Water (%)not stated2.18
Counter-ion (%)not stated7.91
Peptide content (%w/w)not stated89.08
Endotoxin (EU/mg)not stated0.43
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 (4 d) → laboratory (courier, cold pack, 6 d) → assay.
Assay date
05 Sep 2025
Submitted to the index
21 Sep 2025
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
No relationship between submitter and supplier is declared on this record, and the contributor register holds none. That is the default and it is what the provenance class asserts.
Purity 97.93 % with des-Aib20 analogue at 0.87 % nearby. Read the pair together: the purity figure and its nearest neighbour are two views of one integration decision.
kf_titrand
The index re-derives recovered mass from gross fill and target content on every record, and the build check re-derives it again from the published CSV. 10.66 mg is arithmetic, not a claim.
Section 7

Related records

Same batch — lot GGPE-2508-E1731 n=10

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020234GGPE-2508-E1731Janoshik2025-Q397.462.13107.1Buyer-sourced0PASS
AX-2025-020235GGPE-2508-E1731Nordanalyt2025-Q397.692.6396.3Buyer-sourced0PASS
AX-2025-020236GGPE-2508-E1731Janoshik2025-Q397.793.0697.7Buyer-sourced0PASS
AX-2025-020237GGPE-2508-E1731Kestrel2025-Q398.611.92106.7Buyer-sourced1FAIL
AX-2025-020238GGPE-2508-E1731Nordanalyt2025-Q398.033.2090.4Buyer-sourced0PASS
AX-2025-020240GGPE-2508-E1731Medutest2025-Q398.702.30Supplier-supplied0PASS
AX-2025-020241GGPE-2508-E1731Janoshik2025-Q397.452.83Buyer-sourced1FAIL
AX-2025-020242GGPE-2508-E1731Janoshik2025-Q398.372.2897.3Supplier-supplied0PASS
AX-2025-020243GGPE-2508-E1731Medutest2025-Q398.122.8293.6Buyer-sourced0PASS
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 GGPeps records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042784CJC-1295 (no DAC)GGPE-2606-E1234Medutest2026-Q398.274.55Buyer-sourced0PASS
AX-2026-042786CJC-1295 (no DAC)GGPE-2606-E1234Janoshik2026-Q398.223.77Buyer-sourced0PASS
AX-2026-042858SelankGGPE-2603-J2447VendorInvestigate2026-Q398.878.8599.4Buyer-sourced0FAIL
AX-2026-042783CJC-1295 (no DAC)GGPE-2606-E1234Janoshik2026-Q398.224.4590.6Buyer-sourced0PASS
AX-2026-042757Melanotan IIGGPE-2603-P1474Janoshik2026-Q399.546.7892.0Buyer-sourced0PASS
AX-2026-042785CJC-1295 (no DAC)GGPE-2606-E1234PeptideMeter2026-Q397.704.6491.4Buyer-sourced0FAIL
AX-2026-042756Melanotan IIGGPE-2603-P1474Nordanalyt2026-Q399.177.04Buyer-sourced0PASS
AX-2026-042755Melanotan IIGGPE-2603-P1474Nordanalyt2026-Q399.256.5890.4Buyer-sourced0PASS