AX-2026-043657
MGF · 2 mg declared · PolyPeptide Group (Hangzhou) Co., Ltd. · lot PPG-2512-G7713
- Report ID
- AX-2026-043657
- Compound
- MGF
- Compound class
- Growth-hormone axis peptides
- Supplier
- PPG — PolyPeptide Group (Hangzhou) Co., Ltd.
- Batch / lot
- PPG-2512-G7713
- Declared label claim
- 2mg
- Laboratory
- Janoshik Analytical
- Assay date
- 16 May 2026
- Submitted
- 07 Jun 2026
- Quarter
- 2026-Q2
- Submitter
- a.karlsen
- 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, 30 min gradient, 214 nm | 99.06 | % area | ≥ 97.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 0.94 | % area | ≤ 2.5 | PASS |
| Largest single impurity | RP-HPLC — deamidated (+1 Da) | 0.37 | % area | ≤ 1.00 | PASS |
| Identity | not ordered on this submission | not determined | — | required for VERIFIED status | NOT TESTED |
| Total peptide content | by difference from the gravimetric mass balance | 89.97 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 89.12 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 2.40 | mg | 2 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 2.139 | mg | 2 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 107.0 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 4.25 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 5.10 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.68 | % | — | NOT TESTED |
| Endotoxin | kinetic chromogenic LAL | 0.61 | EU/mg | ≤ 5.0 | PASS |
| Sterility | not ordered on this submission | not determined | — | no growth | NOT TESTED |
| 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 | Clear, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 5.01 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 30 min gradient | 11.70 | min | 11.62 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 0.86 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 63,106 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs deamidated (+1 Da) | 1.26 | — | 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 | 11.70 | 4,814,623 | 99.06 | — |
| 2 | deamidated (+1 Da) | 11.46 | 17,983 | 0.37 | +0.984 |
| 3 | acetyl adduct (+42 Da) | 12.10 | 11,665 | 0.24 | +42.011 |
| 4 | truncated (1-20) | 10.48 | 11,179 | 0.23 | -486.271 |
| 5 | aspartimide (−18 Da) | 12.02 | 4,860 | 0.10 | -18.011 |
| 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.
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 | 4.25 |
| Counter-ion (acetate) | ion chromatography | 5.10 |
| Residual solvent + inorganic residue | estimated | 0.68 |
| Total peptide content | by difference | 89.97 |
| 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) | 99.63 | 99.06 | divergence +0.34 pp vs batch median |
| Total impurities (% area) | not stated | 0.94 | |
| Largest single impurity (% area) | not stated | 0.37 | |
| Water (%) | not stated | 4.25 | |
| Counter-ion (%) | 8.9 | 5.10 | |
| Peptide content (%w/w) | 87.0 | 89.97 | |
| Endotoxin (EU/mg) | not stated | 0.61 | |
| Method stated on certificate | YES | — | column, gradient and wavelength given |
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
- Domestic warehouse despatch → submitter (2–8 °C, 12 d) → laboratory (courier, cold pack, 2 d) → assay.
- Assay date
- 16 May 2026
- Submitted to the index
- 07 Jun 2026
- Laboratory
- Janoshik Analytical, Ostrava, Czechia
- Method basis
- 30 min gradient · high-resolution MS
- Verification status
- PURITY ONLY
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot PPG-2512-G7713 n=9
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043652 | PPG-2512-G7713 | Janoshik | 2026-Q2 | 99.33 | 3.87 | 101.6 | Buyer-sourced | 0 | PASS |
| AX-2026-043653 | PPG-2512-G7713 | Janoshik | 2026-Q2 | 99.21 | 4.69 | 102.4 | Buyer-sourced | 0 | PASS |
| AX-2026-043654 | PPG-2512-G7713 | Janoshik | 2026-Q2 | 99.34 | 4.83 | 92.8 | Buyer-sourced | 0 | PASS |
| AX-2026-043655 | PPG-2512-G7713 | Medutest | 2026-Q2 | 99.03 | 4.14 | 99.6 | Buyer-sourced | 0 | PASS |
| AX-2026-043656 | PPG-2512-G7713 | PeptideMeter | 2026-Q2 | 99.09 | 4.22 | 99.3 | Buyer-sourced | 0 | PASS |
| AX-2026-043658 | PPG-2512-G7713 | Medutest | 2026-Q2 | 99.45 | 5.60 | 101.9 | Buyer-sourced | 0 | PASS |
| AX-2026-043659 | PPG-2512-G7713 | Nordanalyt | 2026-Q2 | 99.29 | 4.41 | 102.5 | Buyer-sourced | 0 | PASS |
| AX-2026-043660 | PPG-2512-G7713 | Janoshik | 2026-Q2 | 99.30 | 4.25 | 95.8 | Buyer-sourced | 0 | PASS |
Cross-sections
- All MGF records n=37
- All PPG records n=213
- All Janoshik records n=2989
- All 2026-Q2 records n=1126
- 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-2026-043466 | 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 |
| AX-2026-043653 | PPG | PPG-2512-G7713 | Janoshik | 2026-Q2 | 99.21 | 4.69 | 102.4 | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043598 | Tesamorelin | PPG-2608-A6835 | Kestrel | 2026-Q3 | 98.91 | 2.56 | 100.3 | Buyer-sourced | 1 | FAIL |
| AX-2026-043597 | Tesamorelin | PPG-2608-A6835 | Janoshik | 2026-Q3 | 98.54 | 1.15 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043596 | Tesamorelin | PPG-2608-A6835 | PeptideMeter | 2026-Q3 | 98.74 | 1.83 | 105.1 | Buyer-sourced | 1 | MARGINAL |
| AX-2026-043605 | Retatrutide | PPG-2604-X7060 | Janoshik | 2026-Q2 | 98.17 | 4.29 | 99.7 | Buyer-sourced | 0 | PASS |
| AX-2026-043601 | Retatrutide | PPG-2604-X7060 | Janoshik | 2026-Q2 | 98.28 | 3.96 | 95.3 | Buyer-sourced | 0 | PASS |
| AX-2026-043668 | AOD-9604 | PPG-2602-W8018 | PeptideMeter | 2026-Q2 | 99.47 | 3.06 | — | Buyer-sourced | 0 | PASS |
| AX-2026-043670 | AOD-9604 | PPG-2602-W8018 | PeptideMeter | 2026-Q2 | 99.56 | 2.71 | 104.5 | Buyer-sourced | 0 | PASS |
| AX-2026-043630 | CJC-1295 (no DAC) | PPG-2512-D7211 | Janoshik | 2026-Q2 | 99.66 | 5.11 | 92.5 | Buyer-sourced | 0 | PASS |