AssayIndex

AX-2026-042562

Tirzepatide · 20 mg declared · Hubei Jianxiang Bioscience Co., Ltd. · lot HJ-2605-D6191

MARGINALVERIFIED
Report ID
AX-2026-042562
Compound
Tirzepatide
Compound class
Incretin analogues and co-agonists
Supplier
HJ — Hubei Jianxiang Bioscience Co., Ltd.
Batch / lot
HJ-2605-D6191
Declared label claim
20mg
Laboratory
Nordanalyt Laboratories
Assay date
09 Apr 2026
Submitted
23 Apr 2026
Quarter
2026-Q2
Submitter
l.lokken
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, 35 min gradient, 214 nm98.54% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks1.46% area≤ 3.0PASS
Largest single impurityRP-HPLC — C20 diacid mono-amide0.86% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula4810.4103Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4810.4291Da—NOT TESTED
Mass accuracyobserved vs theoretical+3.9ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance89.31%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity88.01%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen23.99mg20 mg declaredNOT TESTED
Recovered target peptidegross fill × target content21.114mg20 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim105.6%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.60%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography5.63%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.46%—NOT TESTED
Endotoxinnot ordered on this submissionnot determined—≤ 5.0NOT TESTED
Sterilitynot ordered on this submissionnot determined—no growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite 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 calibration4.52—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient21.89min22.91 ± 0.45 (normalised)FAIL
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.11—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²44,084—≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib13]-diastereomer0.52—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.

01037207431114149 Tirzepatide21.89 min · 98.54 % 23.7821.4826.53 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0510152025303540 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 35 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 44,084, and skew follows the reported asymmetry factor of 1.11. 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 0.86 % impurity against a 98.54 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Tirzepatide — main peak21.894,789,34998.54—
2C20 diacid mono-amide23.7841,7990.86+0.984
3des-Aib2 analogue21.4817,9830.37-85.053
4des-Gly deletion (−57 Da)21.186,3180.13-57.021
5[D-Aib13]-diastereomer21.672,4300.050.000
6truncated (3-39)20.161,4580.03-222.112
7tirzepatide dimer26.539720.02+4810.410
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 4810.4103 Da, computed from C225H348N48O68. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100575775975117513751575 [M+5H]5+963.09[M+4H]4+1203.61[M+6H]6+802.75 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 4810.4291 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+688.2087688.21140.00279.0
6+802.7423802.74550.003260.4
5+963.0893963.09310.0038100.0
4+1203.60991203.61460.004760.5
3+1604.47741604.48360.00628.2
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 Fischer4.60
Counter-ion (TFA)ion chromatography5.63
Residual solvent + inorganic residueestimated0.46
Total peptide contentby difference89.31
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)98.598.54divergence -0.10 pp vs batch median
Total impurities (% area)1.501.46
Largest single impurity (% area)not stated0.86
Water (%)not stated4.60
Counter-ion (%)7.85.63
Peptide content (%w/w)88.189.31
Endotoxin (EU/mg)not statednot determined
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 (2–8 °C, 10 d) → laboratory (courier, ambient, 12 d) → assay.
Assay date
09 Apr 2026
Submitted to the index
23 Apr 2026
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 min gradient · high-resolution MS
Verification status
VERIFIED
Section 6

Annotations 4

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.

ppm_error
Well inside class limit. Worth noting that the class limits are set by mass rather than globally, because the same ppm is a different number of daltons at 340 and at 4,800.
nmr_qnmr
Mass at +3.9 ppm establishes identity but not content. Absolute content needs a standard or an orthogonal quantitative method, and neither is a mass spectrometer.
ms_confirm
An orthogonal identity method on the same lot would make this the strongest class of record the index holds. Mass plus retention is already better than most.
round_numbers
The declared figure for HJ-2605-D6191 and the independent median differ by less than the inter-lab limits of agreement. That is the comparison that matters and the rounding does not change it.
Section 7

Related records

Same batch — lot HJ-2605-D6191 n=7

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042559HJ-2605-D6191VendorInvestigate2026-Q298.144.2293.5Buyer-sourced1MARGINAL
AX-2026-042560HJ-2605-D6191Janoshik2026-Q298.604.58104.6Buyer-sourced1MARGINAL
AX-2026-042561HJ-2605-D6191Medutest2026-Q298.634.5494.1Buyer-sourced1MARGINAL
AX-2026-042563HJ-2605-D6191Janoshik2026-Q298.424.60—Buyer-sourced1MARGINAL
AX-2026-042564HJ-2605-D6191Janoshik2026-Q298.653.92—Buyer-sourced1MARGINAL
AX-2026-042565HJ-2605-D6191Kestrel2026-Q298.844.03102.2Buyer-sourced2FAIL

Cross-sections

Other recent Tirzepatide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043288CPCCPC-2607-L1516Janoshik2026-Q396.895.11101.1Laboratory-retained0FAIL
AX-2026-041610FGPFGP-2603-L7753Janoshik2026-Q398.812.45101.0Buyer-sourced0PASS
AX-2026-041974AMBAMB-2603-C5112Nordanalyt2026-Q398.203.41—Buyer-sourced0PASS
AX-2026-041975AMBAMB-2603-C5112Medutest2026-Q397.883.45106.9Laboratory-retained0PASS
AX-2026-041609FGPFGP-2603-L7753Janoshik2026-Q398.522.0098.0Buyer-sourced0PASS
AX-2026-041978AMBAMB-2603-C5112Janoshik2026-Q397.943.57103.0Buyer-sourced0PASS
AX-2026-041982AMBAMB-2603-C5112Janoshik2026-Q397.604.46—Buyer-sourced0PASS
AX-2026-043286CPCCPC-2607-L1516Kestrel2026-Q398.204.56—Buyer-sourced0PASS
Other recent HJ records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042595SemaglutideHJ-2608-C7002Janoshik2026-Q399.503.55—Buyer-sourced1MARGINAL
AX-2026-042598SemaglutideHJ-2608-C7002Janoshik2026-Q399.593.84—Buyer-sourced0PASS
AX-2026-042605SemaglutideHJ-2608-C7002Janoshik2026-Q399.033.37107.3Buyer-sourced0PASS
AX-2026-042602SemaglutideHJ-2608-C7002Nordanalyt2026-Q399.213.5092.0Buyer-sourced0PASS
AX-2026-042603SemaglutideHJ-2608-C7002Janoshik2026-Q399.163.42105.9Buyer-sourced0PASS
AX-2026-042528GHRP-6HJ-2603-R5329VendorInvestigate2026-Q398.691.8795.8Buyer-sourced0FAIL
AX-2026-042526GHRP-6HJ-2603-R5329Medutest2026-Q399.373.06—Laboratory-retained0PASS
AX-2026-042527GHRP-6HJ-2603-R5329VendorInvestigate2026-Q399.212.7793.2Buyer-sourced0PASS