AX-2025-020704
MGF · 2 mg declared · Sangon Biotech (Shanghai) Co., Ltd. · lot SGN-2503-S9261
- Report ID
- AX-2025-020704
- Compound
- MGF
- Compound class
- Growth-hormone axis peptides
- Supplier
- SGN — Sangon Biotech (Shanghai) Co., Ltd.
- Batch / lot
- SGN-2503-S9261
- Declared label claim
- 2mg
- Laboratory
- PeptideMeter
- Assay date
- 16 May 2025
- Submitted
- 25 May 2025
- Quarter
- 2025-Q2
- Submitter
- k.nascimento
- Sample provenance
- Buyer-sourced
Results
Measured against the index acceptance specification for the growth-hormone axis peptides 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, 28 min gradient, 214 nm | 99.39 | % area | ≥ 97.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.61 | % area | ≤ 2.5 | PASS |
| Largest single impurity | RP-HPLC — truncated (1-20) | 0.23 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 2886.5117 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 2886.5267 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | +5.2 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 91.87 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 91.31 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.29 | mg | 2 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 2.091 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 104.6 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 3.50 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 3.89 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.74 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.59 | EU/mg | ≤ 5.0 | PASS |
| Sterility | membrane filtration, USP <71>, 14 d | No growth at 14 d | — | no growth | PASS |
| Appearance | visual, diffuse light, black and white background | White lyophilised cake, intact | — | white to off-white intact cake | PASS |
| Reconstitution clarity | reconstituted per submitter procedure | Faint haze, clearing on standing | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 5.09 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 28 min gradient | 10.94 | min | 10.91 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.87 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 66,427 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs deamidated (+1 Da) | 1.29 | — | no index criterion | REPORTED |
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 | MGF — main peak | 10.94 | 4,830,662 | 99.39 | — |
| 2 | truncated (1-20) | 9.80 | 11,179 | 0.23 | -486.271 |
| 3 | acetyl adduct (+42 Da) | 11.31 | 10,207 | 0.21 | +42.011 |
| 4 | aspartimide (−18 Da) | 11.24 | 4,374 | 0.09 | -18.011 |
| 5 | deamidated (+1 Da) | 10.72 | 3,888 | 0.08 | +0.984 |
| 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.
Mass spectrum and identity
Theoretical monoisotopic mass 2886.5117 Da, computed from C121H200N42O37. All ppm figures on this site are against monoisotopic values — see why that matters.
| Charge | Theoretical m/z | Observed m/z | Δ m/z | Rel. abundance (%) |
|---|---|---|---|---|
| 5+ | 578.3096 | 578.3126 | 0.0030 | 8.7 |
| 4+ | 722.6352 | 722.6390 | 0.0038 | 49.4 |
| 3+ | 963.1778 | 963.1828 | 0.0050 | 100.0 |
| 2+ | 1444.2631 | 1444.2706 | 0.0075 | 49.7 |
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 | 3.50 |
| Counter-ion (acetate) | ion chromatography | 3.89 |
| Residual solvent + inorganic residue | estimated | 0.74 |
| Total peptide content | by difference | 91.87 |
| 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) | 99.49 | 99.39 | divergence +0.10 pp vs batch median |
| Total impurities (% area) | 0.51 | 0.61 | |
| Largest single impurity (% area) | 0.25 | 0.23 | |
| Water (%) | not stated | 3.50 | |
| Counter-ion (%) | not stated | 3.89 | |
| Peptide content (%w/w) | not stated | 91.87 | |
| Endotoxin (EU/mg) | 0.31 | 0.59 | |
| Method stated on certificate | NO | — | no method section — the result cannot be reconciled against any other |
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, 33 d) → laboratory (hand-carried, 8 d) → assay.
- Assay date
- 16 May 2025
- Submitted to the index
- 25 May 2025
- Laboratory
- PeptideMeter, Tallinn, Estonia
- Method basis
- 28 min gradient · high-resolution MS
- Verification status
- VERIFIED
Annotations 2
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.
Related records
Same batch — lot SGN-2503-S9261 n=3
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2025-020705 | SGN-2503-S9261 | PeptideMeter | 2025-Q2 | 99.35 | 3.18 | 92.6 | Buyer-sourced | 0 | PASS |
| AX-2025-020706 | SGN-2503-S9261 | Janoshik | 2025-Q2 | 99.48 | 3.35 | — | Buyer-sourced | 1 | MARGINAL |
Cross-sections
- All MGF records n=37
- All SGN records n=221
- All PeptideMeter records n=1116
- All 2025-Q2 records n=619
- MGF by supplier
- MGF impurity profile
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043660 | PPG | PPG-2512-G7713 | Janoshik | 2026-Q2 | 99.30 | 4.25 | 95.8 | Buyer-sourced | 0 | PASS |
| AX-2026-043656 | PPG | PPG-2512-G7713 | PeptideMeter | 2026-Q2 | 99.09 | 4.22 | 99.3 | Buyer-sourced | 0 | PASS |
| AX-2026-043657 | PPG | PPG-2512-G7713 | Janoshik | 2026-Q2 | 99.06 | 4.25 | 107.0 | Buyer-sourced | 0 | PASS |
| AX-2026-043466 | BCH | BCH-2511-D5168 | Janoshik | 2026-Q2 | 99.04 | 5.33 | 103.5 | Buyer-sourced | 0 | PASS |
| AX-2026-043464 | BCH | BCH-2511-D5168 | VendorInvestigate | 2026-Q2 | 99.39 | 5.79 | 100.2 | Buyer-sourced | 0 | PASS |
| AX-2026-043655 | PPG | PPG-2512-G7713 | Medutest | 2026-Q2 | 99.03 | 4.14 | 99.6 | Buyer-sourced | 0 | PASS |
| AX-2026-043467 | BCH | BCH-2511-D5168 | Janoshik | 2026-Q2 | 99.46 | 5.95 | — | Supplier-supplied | 0 | PASS |
| AX-2026-043652 | PPG | PPG-2512-G7713 | Janoshik | 2026-Q2 | 99.33 | 3.87 | 101.6 | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043233 | Afamelanotide | SGN-2602-Y9306 | Janoshik | 2026-Q3 | 98.76 | 4.02 | 92.2 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043234 | Afamelanotide | SGN-2602-Y9306 | Kestrel | 2026-Q3 | 99.93 | 4.16 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043240 | SLU-PP-332 | SGN-2602-X9377 | Janoshik | 2026-Q2 | 98.82 | 5.46 | 97.0 | Buyer-sourced | 0 | PASS |
| AX-2026-043222 | ARA-290 | SGN-2605-X9069 | PeptideMeter | 2026-Q2 | 98.32 | 7.36 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043237 | SLU-PP-332 | SGN-2602-X9377 | Janoshik | 2026-Q2 | 98.47 | 6.22 | 100.0 | Supplier-supplied | 0 | PASS |
| AX-2026-043227 | ARA-290 | SGN-2605-X9069 | PeptideMeter | 2026-Q2 | 98.38 | 7.21 | 95.6 | Buyer-sourced | 0 | PASS |
| AX-2026-043239 | SLU-PP-332 | SGN-2602-X9377 | VendorInvestigate | 2026-Q2 | 98.28 | 5.37 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043229 | ARA-290 | SGN-2605-X9069 | Janoshik | 2026-Q2 | 98.21 | 7.43 | — | Buyer-sourced | 0 | PASS |