AssayIndex

AX-2026-041805

Tirzepatide · 30 mg declared · Flourishglobal Peptide Biotech (Chengdu) Co., Ltd. · lot FGP-2605-R1831

MARGINALPURITY ONLY
Report ID
AX-2026-041805
Compound
Tirzepatide
Compound class
Incretin analogues and co-agonists
Supplier
FGP — Flourishglobal Peptide Biotech (Chengdu) Co., Ltd.
Batch / lot
FGP-2605-R1831
Declared label claim
30mg
Laboratory
PeptideMeter
Assay date
17 Apr 2026
Submitted
30 Apr 2026
Quarter
2026-Q2
Submitter
sample_vs_retail
Sample provenance
Supplier-supplied
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, 28 min gradient, 214 nm97.49% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks2.51% area≤ 3.0PASS
Largest single impurityRP-HPLC — Met(O) sulfoxide (+16 Da)1.22% area≤ 1.00FAIL
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate6.00%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography6.60%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.74%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 backgroundOff-white 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 calibration3.572.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient18.75min18.64 ± 0.45 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.170.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²67,551≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib13]-diastereomer0.60no 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.

01442288443275769 Tirzepatide18.75 min · 97.49 % 18.0620.2622.46 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 051015202530 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 28 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 67,551, and skew follows the reported asymmetry factor of 1.17. 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 1.22 % impurity against a 97.49 % 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 peak18.754,738,31697.49
2Met(O) sulfoxide (+16 Da)18.0659,2961.22+15.995
3des-Aib2 analogue18.4240,3410.83-85.053
4[D-Aib13]-diastereomer18.5715,0670.310.000
5trifluoroacetyl adduct (+96 Da)19.624,8600.10+95.982
6C20 diacid mono-amide20.261,4580.03+0.984
7tirzepatide dimer22.469720.02+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 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.

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)98.4897.49divergence +0.78 pp vs batch median
Total impurities (% area)1.522.51
Largest single impurity (% area)0.741.22
Water (%)not stated6.00
Counter-ion (%)not stated6.60
Peptide content (%w/w)not statednot determined
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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 8 d) → assay. Submitter did not handle the vial.
Assay date
17 Apr 2026
Submitted to the index
30 Apr 2026
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 min gradient · high-resolution MS
Verification status
PURITY ONLY
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 FGP-2605-R1831 n=15

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041801FGP-2605-R1831Janoshik2026-Q297.707.19Supplier-supplied2MARGINAL
AX-2026-041802FGP-2605-R1831Medutest2026-Q298.076.43Supplier-supplied2MARGINAL
AX-2026-041803FGP-2605-R1831PeptideMeter2026-Q298.266.01104.9Supplier-supplied2MARGINAL
AX-2026-041804FGP-2605-R1831Janoshik2026-Q297.676.4792.2Buyer-sourced2MARGINAL
AX-2026-041806FGP-2605-R1831Janoshik2026-Q297.656.22Supplier-supplied2MARGINAL
AX-2026-041807FGP-2605-R1831Janoshik2026-Q298.116.4796.6Supplier-supplied2MARGINAL
AX-2026-041808FGP-2605-R1831PeptideMeter2026-Q297.955.9988.5Supplier-supplied3MARGINAL
AX-2026-041809FGP-2605-R1831Nordanalyt2026-Q297.486.7397.8Supplier-supplied2MARGINAL
AX-2026-041810FGP-2605-R1831Nordanalyt2026-Q297.586.8494.3Supplier-supplied2MARGINAL
AX-2026-041811FGP-2605-R1831Medutest2026-Q298.096.2189.8Supplier-supplied3MARGINAL
AX-2026-041812FGP-2605-R1831Kestrel2026-Q298.756.88Supplier-supplied2MARGINAL
AX-2026-041813FGP-2605-R1831PeptideMeter2026-Q297.376.17Supplier-supplied2MARGINAL
AX-2026-041814FGP-2605-R1831Janoshik2026-Q298.016.1990.1Supplier-supplied2MARGINAL
AX-2026-041815FGP-2605-R1831VendorInvestigate2026-Q296.866.01Buyer-sourced2FAIL
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-Q399.705.45Supplier-supplied2MARGINAL
AX-2026-041741FGPFGP-2603-L9714PeptideMeter2026-Q398.622.57Supplier-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-Q399.715.15Supplier-supplied2MARGINAL
AX-2026-043321CPCCPC-2607-L2552Kestrel2026-Q397.845.34Supplier-supplied2MARGINAL
Other recent FGP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041742TirzepatideFGP-2603-L9714Janoshik2026-Q399.372.43105.5Supplier-supplied1MARGINAL
AX-2026-041767SemaglutideFGP-2602-M1508PeptideMeter2026-Q398.652.54Supplier-supplied2FAIL
AX-2026-041741TirzepatideFGP-2603-L9714PeptideMeter2026-Q398.622.57Supplier-supplied1MARGINAL
AX-2026-041772SemaglutideFGP-2602-M1508Janoshik2026-Q399.793.03107.5Supplier-supplied0PASS
AX-2026-041770SemaglutideFGP-2602-M1508VendorInvestigate2026-Q399.331.4890.3Buyer-sourced1MARGINAL
AX-2026-041769SemaglutideFGP-2602-M1508Janoshik2026-Q399.132.5592.9Supplier-supplied1MARGINAL
AX-2026-041768SemaglutideFGP-2602-M1508Janoshik2026-Q398.852.2090.3Supplier-supplied1MARGINAL
AX-2026-041771SemaglutideFGP-2602-M1508Janoshik2026-Q399.412.31Supplier-supplied0PASS