AssayIndex

AX-2026-042046

Retatrutide · 20 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · lot HYB-2509-W6465

PASSIDENTITY CONSISTENT
Report ID
AX-2026-042046
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
HYB — Shenzhen Hybio Pharmaceutical Co., Ltd.
Batch / lot
HYB-2509-W6465
Declared label claim
20mg
Laboratory
Medutest
Assay date
23 Jan 2026
Submitted
28 Jan 2026
Quarter
2026-Q1
Submitter
Contributor #N-3320
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 nm99.58% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.42% area≤ 3.5PASS
Largest single impurityRP-HPLC — truncated (5-39)0.23% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula4728.4871DaNOT TESTED
Identity — observed monoisotopic massLC-MS, unit resolution (single quadrupole)4728.4450DaNOT TESTED
Mass accuracyobserved vs theoretical-8.9ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance89.08%w/wNOT TESTED
Target-compound contenttotal peptide content × purity88.71%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen21.34mg20 mg declaredNOT TESTED
Recovered target peptidegross fill × target content18.931mg20 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim94.7%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.09%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography6.11%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.72%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 backgroundWhite cake, partially collapsedwhite to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureVisible particulates, did not clearclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.762.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient17.61min17.53 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.220.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²52,390≥ 20,000PASS
Resolution to nearest impurityvs oxidised Trp (+16 Da)1.74no 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.

01350270040495399 Retatrutide17.61 min · 99.58 % 16.0118.20 same trace · ×200 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 52,390, and skew follows the reported asymmetry factor of 1.22. 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 0.23 % impurity against a 99.58 % 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 peak17.614,839,89799.58
2truncated (5-39)16.0111,1790.23-428.201
3oxidised Trp (+16 Da)17.063,8880.08+15.995
4aspartimide (−18 Da)18.202,9160.06-18.011
5incomplete Fmoc removal (+222 Da)19.622,4300.05+222.068
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, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 4728.4450 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+676.5054676.4994-0.00608.2
6+789.0885789.0814-0.007151.9
5+946.7047946.6963-0.0084100.0
4+1183.12911183.1185-0.010653.2
3+1577.16961577.1556-0.01407.7
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 Fischer4.09
Counter-ion (TFA)ion chromatography6.11
Residual solvent + inorganic residueestimated0.72
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)98.2599.58divergence +0.02 pp vs batch median
Total impurities (% area)1.750.42
Largest single impurity (% area)not stated0.23
Water (%)1.64.09
Counter-ion (%)not stated6.11
Peptide content (%w/w)not stated89.08
Endotoxin (EU/mg)not statednot 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
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Retail purchase → submitter (ambient, 6 d) → laboratory (courier, cold pack, 4 d) → assay.
Assay date
23 Jan 2026
Submitted to the index
28 Jan 2026
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-resolution MS
Verification status
IDENTITY CONSISTENT
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.

coa_template
The certificate for HYB-2509-W6465 carries a named related-substances table rather than a totals line. That is what makes 99.58 % checkable against this record instead of merely comparable to it.
label_claim
A retail vial is also a test of the label. Declared claim 20 mg against what the gravimetry recovers is a question only a purchased vial can answer honestly.
gc_headspace
Purity 99.58 % describes what fraction of the eluted material is the target. Content describes what fraction of the cake is peptide at all. Both are on this record and neither substitutes for the other.
Section 7

Related records

Same batch — lot HYB-2509-W6465 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042042HYB-2509-W6465Janoshik2026-Q198.224.19100.5Buyer-sourced0PASS
AX-2026-042043HYB-2509-W6465Janoshik2026-Q198.233.54104.3Laboratory-retained0PASS
AX-2026-042044HYB-2509-W6465Medutest2026-Q197.954.25Buyer-sourced0PASS
AX-2026-042045HYB-2509-W6465Janoshik2026-Q198.044.18Buyer-sourced0PASS
AX-2026-042047HYB-2509-W6465Janoshik2026-Q198.853.58Buyer-sourced0PASS
AX-2026-042048HYB-2509-W6465Janoshik2026-Q198.564.07Buyer-sourced0PASS
AX-2026-042049HYB-2509-W6465Nordanalyt2026-Q198.294.09103.8Buyer-sourced0PASS
AX-2026-042050HYB-2509-W6465Janoshik2026-Q198.084.29100.1Buyer-sourced2FAIL
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 HYB records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042083MOTS-cHYB-2606-D7858Medutest2026-Q399.932.02Buyer-sourced0PASS
AX-2026-042090MOTS-cHYB-2606-D7858Janoshik2026-Q399.572.36Buyer-sourced1FAIL
AX-2026-042084MOTS-cHYB-2606-D7858Janoshik2026-Q399.282.79107.3Buyer-sourced0PASS
AX-2026-042087MOTS-cHYB-2606-D7858Janoshik2026-Q399.543.05Buyer-sourced0PASS
AX-2026-042085MOTS-cHYB-2606-D7858Janoshik2026-Q399.512.31Buyer-sourced0PASS
AX-2026-042088MOTS-cHYB-2606-D7858PeptideMeter2026-Q399.222.21Buyer-sourced0PASS
AX-2026-042086MOTS-cHYB-2606-D7858Janoshik2026-Q399.933.02Buyer-sourced1MARGINAL
AX-2026-042091CJC-1295 with DACHYB-2608-E7391Janoshik2026-Q399.385.53Buyer-sourced0PASS