AssayIndex

AX-2026-043081

Tirzepatide · 15 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2605-E6030

MARGINALVERIFIED
Report ID
AX-2026-043081
Compound
Tirzepatide
Compound class
Incretin analogues and co-agonists
Supplier
KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot
KP-2605-E6030
Declared label claim
15mg
Laboratory
VendorInvestigate
Assay date
07 Jun 2026
Submitted
11 Jun 2026
Quarter
2026-Q2
Submitter
s.lindholm
Sample provenance
Laboratory-retained
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 nm97.55% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks2.45% area≤ 3.0PASS
Largest single impurityRP-HPLC — des-Aib2 analogue1.09% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula4810.4103Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4810.3819Da—NOT TESTED
Mass accuracyobserved vs theoretical-5.9ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance86.04%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity83.93%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen16.33mg15 mg declaredNOT TESTED
Recovered target peptidegross fill × target content13.706mg15 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim91.4%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.21%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography8.96%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.79%—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 lyophilised cake, intact—white to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.61—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 32 min gradient21.19min21.08 ± 0.45 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.93—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²58,049—≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib13]-diastereomer0.56—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.

01331266239935324 Tirzepatide21.19 min · 97.55 % 20.8222.92 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 58,049, and skew follows the reported asymmetry factor of 0.93. 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 1.09 % impurity against a 97.55 % 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 peak21.194,741,23297.55—
2des-Aib2 analogue20.8252,9771.09-85.053
3[D-Aib13]-diastereomer20.9941,7990.860.000
4C20 diacid mono-amide22.9213,6090.28+0.984
5Met(O) sulfoxide (+16 Da)20.406,3180.13+15.995
6trifluoroacetyl adduct (+96 Da)22.182,4300.05+95.982
7truncated (3-39)19.611,9440.04-222.112
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+963.08[M+4H]4+1203.60[M+6H]6+802.74 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 4810.3819 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+688.2087688.2047-0.00408.7
6+802.7423802.7376-0.004751.7
5+963.0893963.0837-0.0056100.0
4+1203.60991203.6028-0.007157.3
3+1604.47741604.4679-0.00958.3
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 Fischer4.21
Counter-ion (TFA)ion chromatography8.96
Residual solvent + inorganic residueestimated0.79
Total peptide contentby difference86.04
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)98.3597.55divergence +0.82 pp vs batch median
Total impurities (% area)1.652.45
Largest single impurity (% area)not stated1.09
Water (%)2.74.21
Counter-ion (%)not stated8.96
Peptide content (%w/w)not stated86.04
Endotoxin (EU/mg)not stated1.52
Method stated on certificateNO—no method section — the result cannot be reconciled against any other
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
Laboratory-retained
Evidentiary weight
Provenance documented, selection uncontrolled.
Chain of custody
Laboratory retained sample (−20 °C, 32 d since original receipt) → re-assay.
Assay date
07 Jun 2026
Submitted to the index
11 Jun 2026
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 KP-2605-E6030 n=14

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043072KP-2605-E6030VendorInvestigate2026-Q297.183.6996.7Buyer-sourced1MARGINAL
AX-2026-043073KP-2605-E6030Janoshik2026-Q297.684.22—Supplier-supplied1MARGINAL
AX-2026-043074KP-2605-E6030VendorInvestigate2026-Q297.404.6691.4Buyer-sourced1MARGINAL
AX-2026-043075KP-2605-E6030VendorInvestigate2026-Q297.214.07—Buyer-sourced1MARGINAL
AX-2026-043076KP-2605-E6030Janoshik2026-Q297.683.59104.0Supplier-supplied1MARGINAL
AX-2026-043077KP-2605-E6030VendorInvestigate2026-Q297.443.5791.6Buyer-sourced1MARGINAL
AX-2026-043078KP-2605-E6030PeptideMeter2026-Q297.515.1190.6Supplier-supplied1MARGINAL
AX-2026-043079KP-2605-E6030Kestrel2026-Q298.914.1889.6Supplier-supplied3MARGINAL
AX-2026-043080KP-2605-E6030VendorInvestigate2026-Q297.054.22—Buyer-sourced1MARGINAL
AX-2026-043082KP-2605-E6030Medutest2026-Q298.254.08103.5Supplier-supplied1MARGINAL
AX-2026-043083KP-2605-E6030VendorInvestigate2026-Q297.543.89—Buyer-sourced1MARGINAL
AX-2026-043084KP-2605-E6030Janoshik2026-Q297.403.52—Supplier-supplied1MARGINAL
AX-2026-043085KP-2605-E6030Janoshik2026-Q297.714.30—Buyer-sourced1MARGINAL

Cross-sections

Other recent Tirzepatide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043106KPKP-2608-D5921PeptideMeter2026-Q398.905.45105.4Supplier-supplied2MARGINAL
AX-2026-041742FGPFGP-2603-L9714Janoshik2026-Q399.372.43105.5Supplier-supplied1MARGINAL
AX-2026-043108KPKP-2608-D5921Janoshik2026-Q399.705.45—Supplier-supplied2MARGINAL
AX-2026-041741FGPFGP-2603-L9714PeptideMeter2026-Q398.622.57—Supplier-supplied1MARGINAL
AX-2026-043100KPKP-2608-D5921VendorInvestigate2026-Q398.275.3194.4Buyer-sourced2MARGINAL
AX-2026-043322CPCCPC-2607-L2552Janoshik2026-Q396.794.8896.1Supplier-supplied2FAIL
AX-2026-043111KPKP-2608-D5921PeptideMeter2026-Q399.715.15—Supplier-supplied2MARGINAL
AX-2026-043321CPCCPC-2607-L2552Kestrel2026-Q397.845.34—Supplier-supplied2MARGINAL
Other recent KP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043029RetatrutideKP-2607-H5219Medutest2026-Q395.455.71—Supplier-supplied2FAIL
AX-2026-043030RetatrutideKP-2607-H5219Kestrel2026-Q395.976.9597.1Supplier-supplied2FAIL
AX-2026-043106TirzepatideKP-2608-D5921PeptideMeter2026-Q398.905.45105.4Supplier-supplied2MARGINAL
AX-2026-043108TirzepatideKP-2608-D5921Janoshik2026-Q399.705.45—Supplier-supplied2MARGINAL
AX-2026-043039RetatrutideKP-2607-H5219Janoshik2026-Q396.145.62—Supplier-supplied2FAIL
AX-2026-043100TirzepatideKP-2608-D5921VendorInvestigate2026-Q398.275.3194.4Buyer-sourced2MARGINAL
AX-2026-043090IpamorelinKP-2606-D5887Janoshik2026-Q398.183.07101.2Laboratory-retained1FAIL
AX-2026-043028RetatrutideKP-2607-H5219Janoshik2026-Q396.526.09—Supplier-supplied2MARGINAL