AssayIndex

AX-2026-043675

MGF · 5 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2511-D7462

MARGINALIDENTITY CONSISTENT
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
Section 1

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.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 25 min gradient, 214 nm98.92% area≥ 97.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.08% area≤ 2.5PASS
Largest single impurityRP-HPLC — acetyl adduct (+42 Da)0.62% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula2886.5117DaNOT TESTED
Identity — observed monoisotopic massLC-MS, unit resolution (single quadrupole)2886.4961DaNOT TESTED
Mass accuracyobserved vs theoretical-5.4ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance86.20%w/wNOT TESTED
Target-compound contenttotal peptide content × purity85.27%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen5.33mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content4.545mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim90.9%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate6.74%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography6.26%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.80%NOT TESTED
Endotoxinnot ordered on this submissionnot determined≤ 5.0NOT TESTED
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear with a single visible fibreclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.872.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient9.85min9.84 ± 0.30 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.010.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²63,983≥ 20,000PASS
Resolution to nearest impurityvs deamidated (+1 Da)1.25no index criterionREPORTED
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.

029265852877811704 MGF9.85 min · 98.92 % 10.18 same trace · ×100 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0481216202428 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 25 min gradient, 214 nm. Drawn from the peak-integration table below: peak positions are the reported retention times, peak areas are the reported area percentages, peak widths follow the reported plate count of 63,983, and skew follows the reported asymmetry factor of 1.01. Baseline noise is seeded from the report ID and is illustrative. The lower panel is the same trace at a stated vertical expansion with the slow gradient drift subtracted, because at full scale a 0.62 % impurity against a 98.92 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1MGF — main peak9.854,807,81998.92
2acetyl adduct (+42 Da)10.1830,1340.62+42.011
3aspartimide (−18 Da)10.1210,2070.21-18.011
4truncated (1-20)8.838,7490.18-486.271
5deamidated (+1 Da)9.653,4020.07+0.984
Closure check — purity + Σ impurities 100.00CLOSES

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 3

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.

0255075100450650850105012501450 [M+3H]3+963.17[M+2H]2+1444.26[M+4H]4+722.63 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 2886.4961 Da. Sodium (+21.982/z) and potassium (+37.956/z) adducts are shown where the parent charge state exceeds 25 % relative abundance; they are adducts of the same molecule and are not impurities.
ChargeTheoretical m/zObserved m/zΔ m/zRel. abundance (%)
5+578.3096578.3065-0.00318.6
4+722.6352722.6313-0.003953.7
3+963.1778963.1726-0.0052100.0
2+1444.26311444.2553-0.007857.6
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.

ComponentDetermination%w/w of cake
WaterKarl Fischer6.74
Counter-ion (acetate)ion chromatography6.26
Residual solvent + inorganic residueestimated0.80
Total peptide contentby difference86.20
Total100.00 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.

FigureSupplier COAThis reportIndex note
Purity (% area)99.098.92divergence +0.08 pp vs batch median
Total impurities (% area)not stated1.08
Largest single impurity (% area)not stated0.62
Water (%)3.56.74
Counter-ion (%)5.76.26
Peptide content (%w/w)90.286.20
Endotoxin (EU/mg)0.63not determined
Method stated on certificateNOno 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, 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
Section 6

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.

ms_confirm
-5.4 ppm at this mass is a clean identity confirmation. With retention at 9.85 min, MGF is established as the species measured. Note what it does not exclude: a mass-identical diastereomer, which no mass measurement of any resolution can.
coa_template
Suppliers who publish a full related-substances table alongside a rounded headline are giving you the precise version in the table. Look there before reading anything into the summary line.
Section 7

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.

Other recent MGF records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042662SWBSWB-2601-E8021Janoshik2026-Q198.564.52Buyer-sourced0PASS
AX-2026-042661SWBSWB-2601-E8021Janoshik2026-Q198.984.9891.1Laboratory-retained0PASS
AX-2026-042869GGPepsGGPE-2506-T1692Janoshik2025-Q498.364.1696.5Laboratory-retained0PASS
AX-2025-020239GGPepsGGPE-2506-T1692Janoshik2025-Q498.574.69103.5Laboratory-retained0PASS
AX-2025-020240GGPepsGGPE-2506-T1692Janoshik2025-Q498.484.48Buyer-sourced0PASS
AX-2025-020238GGPepsGGPE-2506-T1692Janoshik2025-Q498.314.46101.4Laboratory-retained1MARGINAL
AX-2025-019173HYBHYB-2509-X4844Medutest2025-Q499.442.88Buyer-sourced0PASS
AX-2025-019172HYBHYB-2509-X4844Medutest2025-Q499.922.55Buyer-sourced0PASS
Other recent BCH records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043691BPC-157BCH-2603-L7768Janoshik2026-Q398.665.12Supplier-supplied1MARGINAL
AX-2026-043693BPC-157BCH-2603-L7768PeptideMeter2026-Q397.825.2194.9Buyer-sourced0FAIL
AX-2026-043686BPC-157BCH-2603-L7768VendorInvestigate2026-Q397.645.27Buyer-sourced0FAIL
AX-2026-043695BPC-157BCH-2603-L7768Janoshik2026-Q397.615.42Buyer-sourced0FAIL
AX-2026-043726N-Acetyl Semax AmideBCH-2602-E8475Janoshik2026-Q397.899.67104.2Buyer-sourced0FAIL
AX-2026-043688BPC-157BCH-2603-L7768Janoshik2026-Q397.945.56Buyer-sourced0FAIL
AX-2026-043658BPC-157BCH-2603-G6644Janoshik2026-Q398.454.37101.8Supplier-supplied0PASS
AX-2026-043692BPC-157BCH-2603-L7768VendorInvestigate2026-Q397.605.61Buyer-sourced0FAIL