AssayIndex

AX-2024-005278

Tirzepatide · 60 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2407-F4650

MARGINALVERIFIED
Report ID
AX-2024-005278
Compound
Tirzepatide
Compound class
Incretin analogues and co-agonists
Supplier
BCH — Bachem Holding (Suzhou) Co., Ltd.
Batch / lot
BCH-2407-F4650
Declared label claim
60mg
Laboratory
Janoshik Analytical
Assay date
08 Nov 2024
Submitted
16 Nov 2024
Quarter
2024-Q4
Submitter
r.yilmaz
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, 30 min gradient, 214 nm97.33% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks2.67% area≤ 3.0PASS
Largest single impurityRP-HPLC — C20 diacid mono-amide1.18% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula4810.4103Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4810.3843Da—NOT TESTED
Mass accuracyobserved vs theoretical-5.4ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance87.32%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity84.99%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen65.24mg60 mg declaredNOT TESTED
Recovered target peptidegross fill × target content55.447mg60 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim92.4%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.55%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography6.98%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.15%—NOT TESTED
Endotoxinkinetic chromogenic LAL0.29EU/mg≤ 5.0PASS
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 d—no growthPASS
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 calibration3.85—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient19.80min19.86 ± 0.45 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.15—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²69,687—≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib13]-diastereomer0.62—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.

01398279641945592 Tirzepatide19.80 min · 97.33 % 21.4218.3223.78 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, 30 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 69,687, and skew follows the reported asymmetry factor of 1.15. 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 1.18 % impurity against a 97.33 % 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 peak19.804,730,54097.33—
2C20 diacid mono-amide21.4257,3521.18+0.984
3truncated (3-39)18.3232,0780.66-222.112
4[D-Aib13]-diastereomer19.6122,8430.470.000
5tirzepatide dimer23.789,7210.20+4810.410
6des-Aib2 analogue19.453,8880.08-85.053
7trifluoroacetyl adduct (+96 Da)20.733,8880.08+95.982
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 4810.3843 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+688.2087688.2050-0.00377.8
6+802.7423802.7380-0.004354.5
5+963.0893963.0841-0.0052100.0
4+1203.60991203.6034-0.006555.6
3+1604.47741604.4687-0.00878.8
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 Fischer5.55
Counter-ion (TFA)ion chromatography6.98
Residual solvent + inorganic residueestimated0.15
Total peptide contentby difference87.32
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)97.4297.33divergence +0.09 pp vs batch median
Total impurities (% area)1.042.67
Largest single impurity (% area)2.581.18
Water (%)not stated5.55
Counter-ion (%)3.16.98
Peptide content (%w/w)92.887.32
Endotoxin (EU/mg)not stated0.29
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 (ambient, 8 d) → laboratory (courier, cold pack, 7 d) → assay.
Assay date
08 Nov 2024
Submitted to the index
16 Nov 2024
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
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.

ms_confirm
A reference standard on the same sequence would upgrade this from a good mass to a traceable one. The distinction matters where a result is going to be cited rather than merely read.
tbu_residual
No +56 Da satellite in the envelope, which is the residual-protection signature. Its absence is worth as much as the parent mass being right.
lot_traceability
Lot BCH-2407-F4650 on the vial matches the certificate that came with it. That is the check every buyer can do in ten seconds and most do not.
Section 7

Related records

Same batch — lot BCH-2407-F4650 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-005273BCH-2407-F4650Janoshik2024-Q498.154.80—Supplier-supplied2MARGINAL
AX-2024-005274BCH-2407-F4650Janoshik2024-Q497.235.7689.3Buyer-sourced3MARGINAL
AX-2024-005275BCH-2407-F4650Janoshik2024-Q496.985.1893.8Buyer-sourced2FAIL
AX-2024-005276BCH-2407-F4650PeptideMeter2024-Q497.175.02107.1Supplier-supplied2MARGINAL
AX-2024-005277BCH-2407-F4650Janoshik2024-Q497.175.4091.4Buyer-sourced2MARGINAL
AX-2024-005279BCH-2407-F4650Kestrel2024-Q497.815.59—Supplier-supplied2MARGINAL
AX-2024-005280BCH-2407-F4650Kestrel2024-Q498.395.02—Buyer-sourced2MARGINAL
AX-2024-005281BCH-2407-F4650Janoshik2024-Q497.764.9989.9Supplier-supplied3MARGINAL

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 BCH records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043445BPC-157BCH-2603-G4350Nordanalyt2026-Q398.424.8793.6Buyer-sourced1MARGINAL
AX-2026-043440BPC-157BCH-2603-G4350VendorInvestigate2026-Q398.614.11—Buyer-sourced1MARGINAL
AX-2026-043442BPC-157BCH-2603-G4350Janoshik2026-Q398.654.78—Buyer-sourced1MARGINAL
AX-2026-043471CJC-1295 with DACBCH-2607-H5235Janoshik2026-Q397.465.48—Buyer-sourced1FAIL
AX-2026-043477CJC-1295 with DACBCH-2607-H5235VendorInvestigate2026-Q397.625.3299.6Buyer-sourced1MARGINAL
AX-2026-043449BPC-157BCH-2603-G4350Kestrel2026-Q399.744.9291.3Supplier-supplied2MARGINAL
AX-2026-043448BPC-157BCH-2603-G4350Janoshik2026-Q398.554.69106.9Buyer-sourced1MARGINAL
AX-2026-043470CJC-1295 with DACBCH-2607-H5235Janoshik2026-Q397.766.1199.3Supplier-supplied1MARGINAL