AX-2024-005230
Glucagon · 5 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2408-F7210
FAILPURITY ONLY
- Report ID
- AX-2024-005230
- Compound
- Glucagon
- Compound class
- Incretin analogues and co-agonists
- Supplier
- SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
- Batch / lot
- SSA-2408-F7210
- Declared label claim
- 5mg
- Laboratory
- Janoshik Analytical
- Assay date
- 19 Aug 2024
- Submitted
- 10 Sep 2024
- Quarter
- 2024-Q3
- Submitter
- Contributor #G-5517
- 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, 30 min gradient, 214 nm | 97.76 | % area | ≥ 98.0 | FAIL |
| Total impurities | RP-HPLC, sum of reported peaks | 2.24 | % area | ≤ 2.0 | FAIL |
| Largest single impurity | RP-HPLC — deamidated Asn28 (+1 Da) | 1.11 | % 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 | 87.25 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 85.30 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 5.38 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 4.589 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 91.8 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 7.12 | % | ≤ 8.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 4.74 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.89 | % | — | NOT TESTED |
| Endotoxin | not ordered on this submission | not determined | — | ≤ 5.0 | NOT TESTED |
| Sterility | membrane filtration, USP <71>, 14 d | No growth at 14 d | — | no growth | PASS |
| Appearance | visual, diffuse light, black and white background | White to pale-yellow cake, intact | — | white to off-white intact cake | PASS |
| 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 | 5.02 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 13.57 | min | 13.61 ± 0.35 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.13 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 68,489 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs deamidated Asn28 (+1 Da) | 1.69 | — | 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 | Glucagon — main peak | 13.57 | 4,751,439 | 97.76 | — |
| 2 | deamidated Asn28 (+1 Da) | 13.21 | 53,949 | 1.11 | +0.984 |
| 3 | Met27 sulfoxide (+16 Da) | 12.78 | 34,508 | 0.71 | +15.995 |
| 4 | glucagon fibril-derived aggregate | 16.18 | 11,665 | 0.24 | 0.000 |
| 5 | des-His1 (−137 Da) | 12.63 | 8,749 | 0.18 | -137.059 |
| 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 | 7.12 |
| Counter-ion (acetate) | ion chromatography | 4.74 |
| Residual solvent + inorganic residue | estimated | 0.89 |
| Total peptide content | by difference | 87.25 |
| 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) | 98.80 | 97.76 | divergence -0.11 pp vs batch median |
| Total impurities (% area) | 1.20 | 2.24 | |
| Largest single impurity (% area) | not stated | 1.11 | |
| Water (%) | 6.9 | 7.12 | |
| Counter-ion (%) | not stated | 4.74 | |
| Peptide content (%w/w) | not stated | 87.25 | |
| 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 (ambient, 8 d) → laboratory (hand-carried, 10 d) → assay.
- Assay date
- 19 Aug 2024
- Submitted to the index
- 10 Sep 2024
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 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 SSA-2408-F7210 n=7
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-005225 | SSA-2408-F7210 | PeptideMeter | 2024-Q3 | 98.91 | 7.90 | 103.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005226 | SSA-2408-F7210 | Nordanalyt | 2024-Q3 | 99.32 | 7.88 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005227 | SSA-2408-F7210 | Janoshik | 2024-Q3 | 98.64 | 7.53 | 96.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005228 | SSA-2408-F7210 | PeptideMeter | 2024-Q3 | 99.21 | 7.27 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005229 | SSA-2408-F7210 | Janoshik | 2024-Q3 | 99.14 | 7.23 | 92.7 | Supplier-supplied | 2 | MARGINAL |
| AX-2024-005231 | SSA-2408-F7210 | VendorInvestigate | 2024-Q3 | 97.91 | 7.51 | 102.9 | Buyer-sourced | 0 | FAIL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042166 | Homopeptide | HOMO-2602-V9076 | Nordanalyt | 2026-Q2 | 99.85 | 6.11 | 101.5 | Supplier-supplied | 0 | PASS |
| AX-2026-042529 | ERP | ERP-2601-X6637 | Janoshik | 2026-Q1 | 97.90 | 1.86 | 95.6 | Supplier-supplied | 0 | FAIL |
| AX-2026-042530 | ERP | ERP-2601-X6637 | VendorInvestigate | 2026-Q1 | 98.15 | 1.28 | — | Buyer-sourced | 0 | PASS |
| AX-2024-005227 | SSA | SSA-2408-F7210 | Janoshik | 2024-Q3 | 98.64 | 7.53 | 96.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005226 | SSA | SSA-2408-F7210 | Nordanalyt | 2024-Q3 | 99.32 | 7.88 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005225 | SSA | SSA-2408-F7210 | PeptideMeter | 2024-Q3 | 98.91 | 7.90 | 103.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005229 | SSA | SSA-2408-F7210 | Janoshik | 2024-Q3 | 99.14 | 7.23 | 92.7 | Supplier-supplied | 2 | MARGINAL |
| AX-2024-005231 | SSA | SSA-2408-F7210 | VendorInvestigate | 2024-Q3 | 97.91 | 7.51 | 102.9 | Buyer-sourced | 0 | FAIL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043144 | GHK-Cu | SSA-2604-V7620 | Janoshik | 2026-Q2 | 98.35 | 5.25 | 105.8 | Supplier-supplied | 0 | PASS |
| AX-2026-043141 | Semax | SSA-2604-L7628 | Kestrel | 2026-Q2 | 98.84 | 8.58 | 93.2 | Supplier-supplied | 2 | MARGINAL |
| AX-2026-043117 | Mazdutide | SSA-2605-G6781 | Janoshik | 2026-Q2 | 99.23 | 3.67 | 90.4 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043136 | BPC-157 | SSA-2601-N6752 | Janoshik | 2026-Q2 | 97.75 | 4.32 | — | Supplier-supplied | 2 | FAIL |
| AX-2026-043118 | Mazdutide | SSA-2605-G6781 | Medutest | 2026-Q2 | 98.29 | 2.65 | 88.7 | Buyer-sourced | 2 | MARGINAL |
| AX-2026-043138 | BPC-157 | SSA-2601-N6752 | Janoshik | 2026-Q2 | 98.00 | 4.30 | 101.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043137 | BPC-157 | SSA-2601-N6752 | Janoshik | 2026-Q2 | 97.41 | 4.36 | 104.5 | Laboratory-retained | 1 | FAIL |
| AX-2026-043146 | Enclomiphene citrate | SSA-2603-C6950 | Medutest | 2026-Q2 | 97.92 | 3.11 | 92.9 | Buyer-sourced | 2 | FAIL |