AX-2026-043675
MGF · 5 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2511-D7462
- Report ID
- AX-2026-043675
- Compound
- MGF
- Compound class
- Growth-hormone axis peptides
- Supplier
- BCH — Bachem Holding (Suzhou) Co., Ltd.
- Batch / lot
- BCH-2511-D7462
- Declared label claim
- 5mg
- Laboratory
- Medutest
- Assay date
- 15 Jun 2026
- Submitted
- 05 Jul 2026
- Quarter
- 2026-Q2
- Submitter
- ay.boateng
- 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, 25 min gradient, 214 nm | 98.92 | % area | ≥ 97.5 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.08 | % area | ≤ 2.5 | PASS |
| Largest single impurity | RP-HPLC — acetyl adduct (+42 Da) | 0.62 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 2886.5117 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, unit resolution (single quadrupole) | 2886.4961 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -5.4 | ppm | ± 15 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 86.20 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 85.27 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 5.33 | mg | 5 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 4.545 | mg | 5 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 90.9 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 6.74 | % | ≤ 9.0 | PASS |
| Counter-ion (acetate) | anion-exchange ion chromatography | 6.26 | % | ≤ 12.0 | PASS |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.80 | % | — | 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 lyophilised cake, intact | — | white to off-white intact cake | PASS |
| Reconstitution clarity | reconstituted per submitter procedure | Clear with a single visible fibre | — | clear, no visible particulates | FAIL |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 4.87 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 25 min gradient | 9.85 | min | 9.84 ± 0.30 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.01 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 63,983 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs deamidated (+1 Da) | 1.25 | — | 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 | 9.85 | 4,807,819 | 98.92 | — |
| 2 | acetyl adduct (+42 Da) | 10.18 | 30,134 | 0.62 | +42.011 |
| 3 | aspartimide (−18 Da) | 10.12 | 10,207 | 0.21 | -18.011 |
| 4 | truncated (1-20) | 8.83 | 8,749 | 0.18 | -486.271 |
| 5 | deamidated (+1 Da) | 9.65 | 3,402 | 0.07 | +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 | 578.3065 | -0.0031 | 8.6 |
| 4+ | 722.6352 | 722.6313 | -0.0039 | 53.7 |
| 3+ | 963.1778 | 963.1726 | -0.0052 | 100.0 |
| 2+ | 1444.2631 | 1444.2553 | -0.0078 | 57.6 |
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 | 6.74 |
| Counter-ion (acetate) | ion chromatography | 6.26 |
| Residual solvent + inorganic residue | estimated | 0.80 |
| Total peptide content | by difference | 86.20 |
| 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) | 99.0 | 98.92 | divergence +0.08 pp vs batch median |
| Total impurities (% area) | not stated | 1.08 | |
| Largest single impurity (% area) | not stated | 0.62 | |
| Water (%) | 3.5 | 6.74 | |
| Counter-ion (%) | 5.7 | 6.26 | |
| Peptide content (%w/w) | 90.2 | 86.20 | |
| Endotoxin (EU/mg) | 0.63 | not determined | |
| 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 (2–8 °C, 14 d) → laboratory (courier, ambient, 6 d) → assay.
- Assay date
- 15 Jun 2026
- Submitted to the index
- 05 Jul 2026
- Laboratory
- Medutest, Ljubljana, Slovenia
- Method basis
- 25 min gradient · unit-resolution MS
- Verification status
- IDENTITY CONSISTENT
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 BCH-2511-D7462 n=1
This is the only report on this lot. One report is not a batch characterisation.
Cross-sections
- All MGF records n=38
- All BCH records n=316
- All Medutest records n=989
- All 2026-Q2 records n=1102
- MGF by supplier
- MGF impurity profile
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-042662 | SWB | SWB-2601-E8021 | Janoshik | 2026-Q1 | 98.56 | 4.52 | — | Buyer-sourced | 0 | PASS |
| AX-2026-042661 | SWB | SWB-2601-E8021 | Janoshik | 2026-Q1 | 98.98 | 4.98 | 91.1 | Laboratory-retained | 0 | PASS |
| AX-2026-042869 | GGPeps | GGPE-2506-T1692 | Janoshik | 2025-Q4 | 98.36 | 4.16 | 96.5 | Laboratory-retained | 0 | PASS |
| AX-2025-020239 | GGPeps | GGPE-2506-T1692 | Janoshik | 2025-Q4 | 98.57 | 4.69 | 103.5 | Laboratory-retained | 0 | PASS |
| AX-2025-020240 | GGPeps | GGPE-2506-T1692 | Janoshik | 2025-Q4 | 98.48 | 4.48 | — | Buyer-sourced | 0 | PASS |
| AX-2025-020238 | GGPeps | GGPE-2506-T1692 | Janoshik | 2025-Q4 | 98.31 | 4.46 | 101.4 | Laboratory-retained | 1 | MARGINAL |
| AX-2025-019173 | HYB | HYB-2509-X4844 | Medutest | 2025-Q4 | 99.44 | 2.88 | — | Buyer-sourced | 0 | PASS |
| AX-2025-019172 | HYB | HYB-2509-X4844 | Medutest | 2025-Q4 | 99.92 | 2.55 | — | Buyer-sourced | 0 | PASS |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043691 | BPC-157 | BCH-2603-L7768 | Janoshik | 2026-Q3 | 98.66 | 5.12 | — | Supplier-supplied | 1 | MARGINAL |
| AX-2026-043693 | BPC-157 | BCH-2603-L7768 | PeptideMeter | 2026-Q3 | 97.82 | 5.21 | 94.9 | Buyer-sourced | 0 | FAIL |
| AX-2026-043686 | BPC-157 | BCH-2603-L7768 | VendorInvestigate | 2026-Q3 | 97.64 | 5.27 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043695 | BPC-157 | BCH-2603-L7768 | Janoshik | 2026-Q3 | 97.61 | 5.42 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043726 | N-Acetyl Semax Amide | BCH-2602-E8475 | Janoshik | 2026-Q3 | 97.89 | 9.67 | 104.2 | Buyer-sourced | 0 | FAIL |
| AX-2026-043688 | BPC-157 | BCH-2603-L7768 | Janoshik | 2026-Q3 | 97.94 | 5.56 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-043658 | BPC-157 | BCH-2603-G6644 | Janoshik | 2026-Q3 | 98.45 | 4.37 | 101.8 | Supplier-supplied | 0 | PASS |
| AX-2026-043692 | BPC-157 | BCH-2603-L7768 | VendorInvestigate | 2026-Q3 | 97.60 | 5.61 | — | Buyer-sourced | 0 | FAIL |