AssayIndex

AX-2025-019910

PEG-MGF · 5 mg declared · Hubei Jianxiang Bioscience Co., Ltd. · lot HJ-2507-S5943

FAILIDENTITY CONSISTENT
Report ID
AX-2025-019910
Compound
PEG-MGF
Compound class
Growth-hormone axis peptides
Supplier
HJ — Hubei Jianxiang Bioscience Co., Ltd.
Batch / lot
HJ-2507-S5943
Declared label claim
5mg
Laboratory
Medutest
Assay date
18 Jul 2025
Submitted
27 Jul 2025
Quarter
2025-Q3
Submitter
o.silva
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 nm98.36% area≥ 92.0PASS
Total impuritiesRP-HPLC, sum of reported peaks1.64% area≤ 8.0PASS
Largest single impurityRP-HPLC — hydrolysed linker0.81% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula7894.0000DaNOT TESTED
Identity — observed monoisotopic massLC-MS, unit resolution (single quadrupole)7894.1610DaNOT TESTED
Mass accuracyobserved vs theoretical+20.4ppm± 15FAIL
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate6.95%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography1.86%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.48%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 backgroundOff-white lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.292.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient14.59min14.60 ± 0.80 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.070.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²50,502≥ 20,000PASS
Resolution to nearest impurityvs hydrolysed linker2.25no 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.

01694338950836778 PEG-MGF14.59 min · 98.36 % 13.999.9116.13 same trace · ×50 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 50,502, and skew follows the reported asymmetry factor of 1.07. 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 0.81 % impurity against a 98.36 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1PEG-MGF — main peak14.594,780,60198.36
2hydrolysed linker13.9939,3690.81+18.011
3free MGF (unconjugated)9.9116,5250.34-5007.488
4di-PEGylated species16.1313,1230.27+5000.000
5free mPEG16.6110,6930.22-2886.512
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 7894.0000 Da, computed from conjugate (24-mer + 5 kDa mPEG). All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100725850975110012251350 [M+8H]8+987.78[M+9H]9+878.14[M+7H]7+1128.74 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 7894.1610 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 (%)
10+790.4073790.42340.01618.0
9+878.1184878.13630.017957.4
8+987.7573987.77740.0201100.0
7+1128.72161128.74460.023053.4
6+1316.67391316.70080.02697.9
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.

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)98.0798.36divergence -0.09 pp vs batch median
Total impurities (% area)1.931.64
Largest single impurity (% area)not stated0.81
Water (%)5.36.95
Counter-ion (%)not stated1.86
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)0.21not determined
Method stated on certificateYEScolumn, gradient and wavelength given
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 (−20 °C, 31 d) → laboratory (courier, dry ice, 5 d) → assay.
Assay date
18 Jul 2025
Submitted to the index
27 Jul 2025
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-resolution MS
Verification status
IDENTITY CONSISTENT
Section 6

Annotations 4

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
Identity confirmation needs a reference standard and the record does not say whose was used. Where the deviation is small this is the first ambiguity to remove.
buyer_sourced
Buyer-sourced through an ordinary retail order, so the supplier had no opportunity to select the vial. This is the provenance class the index weights and it is roughly 87 % of the dataset.
price_per_mg
A retail purchase carries a price, which makes cost per milligram of recovered peptide computable. That is the comparison a buyer actually needs and it exists only for this provenance class.
sample_vs_retail
Anyone can generate one of these. That is the argument the index makes on its submission page and it is the reason the dataset grows without any supplier's cooperation.
Section 7

Related records

Same batch — lot HJ-2507-S5943 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-019906HJ-2507-S5943Kestrel2025-Q398.547.23Buyer-sourced0PASS
AX-2025-019907HJ-2507-S5943Janoshik2025-Q398.206.75Buyer-sourced0PASS
AX-2025-019908HJ-2507-S5943Janoshik2025-Q398.167.25104.1Buyer-sourced0PASS
AX-2025-019909HJ-2507-S5943Janoshik2025-Q397.657.04Buyer-sourced0PASS
AX-2025-019911HJ-2507-S5943Janoshik2025-Q397.657.0791.8Buyer-sourced0PASS
AX-2025-019912HJ-2507-S5943Janoshik2025-Q397.707.08Buyer-sourced0PASS
AX-2025-019913HJ-2507-S5943Nordanalyt2025-Q398.336.64Buyer-sourced0PASS
AX-2025-019914HJ-2507-S5943Medutest2025-Q398.147.59Buyer-sourced0PASS
Other recent PEG-MGF records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041821ASYASY-{CAT}-2379Janoshik2026-Q298.575.7995.3Buyer-sourced0PASS
AX-2026-043577SIGSIG-2602-6794Kestrel2026-Q297.666.08Buyer-sourced0PASS
AX-2026-043570SIGSIG-2602-6794PeptideMeter2026-Q297.765.45104.2Buyer-sourced0PASS
AX-2026-043569SIGSIG-2602-6794PeptideMeter2026-Q297.525.36Laboratory-retained0PASS
AX-2026-043573SIGSIG-2602-6794Janoshik2026-Q298.584.79104.2Buyer-sourced0PASS
AX-2026-041822ASYASY-{CAT}-2379Janoshik2026-Q298.836.51Laboratory-retained0PASS
AX-2026-043574SIGSIG-2602-6794Kestrel2026-Q298.045.9888.6Buyer-sourced1MARGINAL
AX-2026-043576SIGSIG-2602-6794Nordanalyt2026-Q297.615.56Buyer-sourced0PASS
Other recent HJ records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042595SemaglutideHJ-2608-C7002Janoshik2026-Q399.503.55Buyer-sourced1MARGINAL
AX-2026-042598SemaglutideHJ-2608-C7002Janoshik2026-Q399.593.84Buyer-sourced0PASS
AX-2026-042605SemaglutideHJ-2608-C7002Janoshik2026-Q399.033.37107.3Buyer-sourced0PASS
AX-2026-042602SemaglutideHJ-2608-C7002Nordanalyt2026-Q399.213.5092.0Buyer-sourced0PASS
AX-2026-042603SemaglutideHJ-2608-C7002Janoshik2026-Q399.163.42105.9Buyer-sourced0PASS
AX-2026-042528GHRP-6HJ-2603-R5329VendorInvestigate2026-Q398.691.8795.8Buyer-sourced0FAIL
AX-2026-042526GHRP-6HJ-2603-R5329Medutest2026-Q399.373.06Laboratory-retained0PASS
AX-2026-042527GHRP-6HJ-2603-R5329VendorInvestigate2026-Q399.212.7793.2Buyer-sourced0PASS