AX-2024-005351
Tirzepatide · 30 mg declared · Sigma-Aldrich (Shanghai) Trading Co., Ltd. · lot SIG-2404-6658
PASSPURITY ONLY
- Report ID
- AX-2024-005351
- Compound
- Tirzepatide
- Compound class
- Incretin analogues and co-agonists
- Supplier
- SIG — Sigma-Aldrich (Shanghai) Trading Co., Ltd.
- Batch / lot
- SIG-2404-6658
- Declared label claim
- 30mg
- Laboratory
- Medutest
- Assay date
- 09 Aug 2024
- Submitted
- 25 Aug 2024
- Quarter
- 2024-Q3
- Submitter
- g.nascimento
- 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.
| Parameter | Method | Result | Unit | Index spec | |
|---|---|---|---|---|---|
| Purity | RP-HPLC, 25 min gradient, 214 nm | 97.60 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 2.40 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — des-Aib2 analogue | 1.04 | % area | ≤ 1.00 | FAIL |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 83.18 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 81.18 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 39.25 | mg | 30 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 31.863 | mg | 30 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 106.2 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 7.77 | % | ≤ 8.0 | PASS |
| Counter-ion (TFA) | anion-exchange ion chromatography | 8.08 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.97 | % | — | NOT TESTED |
| Endotoxin | not ordered on this submission | not determined | — | ≤ 5.0 | NOT TESTED |
| Sterility | not ordered on this submission | not determined | — | no growth | NOT TESTED |
| Appearance | visual, diffuse light, black and white background | White cake, partially collapsed | — | white to off-white intact cake | FAIL |
| Reconstitution clarity | reconstituted per submitter procedure | Clear, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 3.48 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 16.87 | min | 16.81 ± 0.45 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.20 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 71,681 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs [D-Aib13]-diastereomer | 0.61 | — | no index criterion | REPORTED |
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.
| # | Peak | RT | Area (µV·s) | % area | Δ mass (Da) |
|---|---|---|---|---|---|
| 1 | Tirzepatide — main peak | 16.87 | 4,743,663 | 97.60 | — |
| 2 | des-Aib2 analogue | 16.58 | 50,547 | 1.04 | -85.053 |
| 3 | trifluoroacetyl adduct (+96 Da) | 17.64 | 44,715 | 0.92 | +95.982 |
| 4 | tirzepatide dimer | 20.19 | 10,693 | 0.22 | +4810.410 |
| 5 | [D-Aib13]-diastereomer | 16.71 | 4,860 | 0.10 | 0.000 |
| 6 | C20 diacid mono-amide | 18.22 | 3,402 | 0.07 | +0.984 |
| 7 | des-Gly deletion (−57 Da) | 16.36 | 2,430 | 0.05 | -57.021 |
| Closure check — purity + Σ impurities | 100.00 | CLOSES | |||
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.
| Component | Determination | %w/w of cake |
|---|---|---|
| Water | Karl Fischer | 7.77 |
| Counter-ion (TFA) | ion chromatography | 8.08 |
| Residual solvent + inorganic residue | estimated | 0.97 |
| Total peptide content | by difference | 83.18 |
| Total | 100.00 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.
| Figure | Supplier COA | This report | Index note |
|---|---|---|---|
| Purity (% area) | 98.41 | 97.60 | divergence +0.83 pp vs batch median |
| Total impurities (% area) | 1.59 | 2.40 | |
| Largest single impurity (% area) | 0.71 | 1.04 | |
| Water (%) | 7.5 | 7.77 | |
| Counter-ion (%) | not stated | 8.08 | |
| Peptide content (%w/w) | not stated | 83.18 | |
| Endotoxin (EU/mg) | not stated | not determined | |
| Method stated on certificate | NO | — | 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
- Buyer-sourced
- Evidentiary weight
- Strongest available evidence in this index.
- Chain of custody
- Retail purchase → submitter (2–8 °C, 7 d) → laboratory (courier, ambient, 12 d) → assay.
- Assay date
- 09 Aug 2024
- Submitted to the index
- 25 Aug 2024
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-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 SIG-2404-6658 n=11
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-005342 | SIG-2404-6658 | Medutest | 2024-Q3 | 97.66 | 8.11 | — | Buyer-sourced | 0 | FAIL |
| AX-2024-005343 | SIG-2404-6658 | Nordanalyt | 2024-Q3 | 97.68 | 7.99 | 98.1 | Buyer-sourced | 0 | PASS |
| AX-2024-005344 | SIG-2404-6658 | VendorInvestigate | 2024-Q3 | 97.51 | 8.05 | 94.4 | Buyer-sourced | 0 | FAIL |
| AX-2024-005345 | SIG-2404-6658 | PeptideMeter | 2024-Q3 | 97.49 | 7.59 | — | Supplier-supplied | 0 | PASS |
| AX-2024-005346 | SIG-2404-6658 | Nordanalyt | 2024-Q3 | 97.55 | 7.85 | 102.9 | Laboratory-retained | 0 | PASS |
| AX-2024-005347 | SIG-2404-6658 | Janoshik | 2024-Q3 | 97.52 | 7.74 | 101.6 | Buyer-sourced | 0 | PASS |
| AX-2024-005348 | SIG-2404-6658 | Janoshik | 2024-Q3 | 97.56 | 7.79 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005349 | SIG-2404-6658 | Janoshik | 2024-Q3 | 97.61 | 8.41 | 92.1 | Buyer-sourced | 0 | FAIL |
| AX-2024-005350 | SIG-2404-6658 | Kestrel | 2024-Q3 | 97.79 | 8.02 | 93.9 | Buyer-sourced | 0 | FAIL |
| AX-2024-005352 | SIG-2404-6658 | Janoshik | 2024-Q3 | 97.58 | 7.96 | — | Buyer-sourced | 0 | PASS |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043288 | CPC | CPC-2607-L1516 | Janoshik | 2026-Q3 | 96.89 | 5.11 | 101.1 | Laboratory-retained | 0 | FAIL |
| AX-2026-041610 | FGP | FGP-2603-L7753 | Janoshik | 2026-Q3 | 98.81 | 2.45 | 101.0 | Buyer-sourced | 0 | PASS |
| AX-2026-041974 | AMB | AMB-2603-C5112 | Nordanalyt | 2026-Q3 | 98.20 | 3.41 | — | Buyer-sourced | 0 | PASS |
| AX-2026-041975 | AMB | AMB-2603-C5112 | Medutest | 2026-Q3 | 97.88 | 3.45 | 106.9 | Laboratory-retained | 0 | PASS |
| AX-2026-041609 | FGP | FGP-2603-L7753 | Janoshik | 2026-Q3 | 98.52 | 2.00 | 98.0 | Buyer-sourced | 0 | PASS |
| AX-2026-041978 | AMB | AMB-2603-C5112 | Janoshik | 2026-Q3 | 97.94 | 3.57 | 103.0 | Buyer-sourced | 0 | PASS |
| AX-2026-041982 | AMB | AMB-2603-C5112 | Janoshik | 2026-Q3 | 97.60 | 4.46 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043286 | CPC | CPC-2607-L1516 | Kestrel | 2026-Q3 | 98.20 | 4.56 | — | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043535 | GHRP-2 | SIG-2603-6031 | Janoshik | 2026-Q3 | 99.12 | 1.26 | 105.7 | Buyer-sourced | 0 | PASS |
| AX-2026-043541 | GHRP-2 | SIG-2603-6031 | PeptideMeter | 2026-Q3 | 99.06 | 2.08 | 107.4 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043539 | GHRP-2 | SIG-2603-6031 | Janoshik | 2026-Q3 | 98.95 | 1.74 | 100.4 | Buyer-sourced | 1 | FAIL |
| AX-2026-043534 | GHRP-2 | SIG-2603-6031 | Medutest | 2026-Q3 | 99.11 | 2.15 | 89.8 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043542 | GHRP-2 | SIG-2603-6031 | VendorInvestigate | 2026-Q3 | 99.05 | 1.43 | — | Buyer-sourced | 1 | FAIL |
| AX-2026-043543 | GHRP-2 | SIG-2603-6031 | Janoshik | 2026-Q3 | 99.38 | 1.70 | 98.6 | Buyer-sourced | 0 | PASS |
| AX-2026-043544 | GHRP-2 | SIG-2603-6031 | PeptideMeter | 2026-Q3 | 99.57 | 1.51 | 105.4 | Buyer-sourced | 0 | PASS |
| AX-2026-043538 | GHRP-2 | SIG-2603-6031 | Kestrel | 2026-Q3 | 98.93 | 1.72 | — | Buyer-sourced | 0 | FAIL |