AssayIndex

AX-2026-042648

Melanotan II · 10 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2603-P8735

MARGINALPURITY ONLY
Report ID
AX-2026-042648
Compound
Melanotan II
Compound class
Melanocortin-receptor peptides
Supplier
GGPeps — Nantong Guangyuan Chemical Co., Ltd.
Batch / lot
GGPE-2603-P8735
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
11 Sep 2026
Submitted
04 Oct 2026
Quarter
2026-Q3
Submitter
i.lindholm
Sample provenance
Supplier-supplied
Section 1

Results

Measured against the index acceptance specification for the melanocortin-receptor 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, 30 min gradient, 214 nm99.10% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.90% area≤ 1.5PASS
Largest single impurityRP-HPLC — linear (open-lactam) precursor (+18 Da)0.59% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate6.97%≤ 8.0PASS
Counter-ion (acetate)anion-exchange ion chromatography4.96%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.43%NOT TESTED
Endotoxinkinetic chromogenic LAL0.90EU/mg≤ 5.0PASS
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 after 90 s gentle swirling, no particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.322.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient10.00min9.84 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.040.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²61,145≥ 20,000PASS
Resolution to nearest impurityvs [L-Phe7]-diastereomer0.96no 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.

027815562834311124 Melanotan II10.00 min · 99.10 % 9.2612.35 same trace · ×100 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 30 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 61,145, and skew follows the reported asymmetry factor of 1.04. 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 0.59 % impurity against a 99.10 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Melanotan II — main peak10.004,816,56799.10
2linear (open-lactam) precursor (+18 Da)9.2628,6760.59+18.011
3MT-II dimer (head-to-tail)12.358,7490.18+1023.540
4oxidised Trp (+16 Da)9.644,3740.09+15.995
5[L-Phe7]-diastereomer9.849720.020.000
6des-acetyl MT-II (−42 Da)9.529720.02-42.011
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 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)99.7499.10divergence +0.23 pp vs batch median
Total impurities (% area)-0.420.90
Largest single impurity (% area)-0.210.59
Water (%)6.26.97
Counter-ion (%)not stated4.96
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)not stated0.90
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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 4 d) → assay. Submitter did not handle the vial.
Assay date
11 Sep 2026
Submitted to the index
04 Oct 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
PURITY ONLY
Section 6

Annotations

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot GGPE-2603-P8735 n=8

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042645GGPE-2603-P8735VendorInvestigate2026-Q398.327.12Buyer-sourced3FAIL
AX-2026-042646GGPE-2603-P8735Janoshik2026-Q399.807.0497.3Supplier-supplied3MARGINAL
AX-2026-042647GGPE-2603-P8735Janoshik2026-Q399.487.06Supplier-supplied4MARGINAL
AX-2026-042649GGPE-2603-P8735PeptideMeter2026-Q399.537.32105.6Supplier-supplied4MARGINAL
AX-2026-042650GGPE-2603-P8735Medutest2026-Q399.866.49Supplier-supplied3MARGINAL
AX-2026-042651GGPE-2603-P8735PeptideMeter2026-Q399.537.0490.7Supplier-supplied4MARGINAL
AX-2026-042652GGPE-2603-P8735Janoshik2026-Q399.366.96Supplier-supplied4MARGINAL
Other recent Melanotan II records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042479SWBSWB-2603-A5707Janoshik2026-Q399.163.6794.5Supplier-supplied1MARGINAL
AX-2026-042481SWBSWB-2603-A5707Medutest2026-Q398.953.3790.8Supplier-supplied1MARGINAL
AX-2026-042650GGPepsGGPE-2603-P8735Medutest2026-Q399.866.49Supplier-supplied3MARGINAL
AX-2026-042483SWBSWB-2603-A5707Janoshik2026-Q399.383.73107.2Supplier-supplied1MARGINAL
AX-2026-042651GGPepsGGPE-2603-P8735PeptideMeter2026-Q399.537.0490.7Supplier-supplied4MARGINAL
AX-2026-042478SWBSWB-2603-A5707VendorInvestigate2026-Q398.734.34Buyer-sourced1MARGINAL
AX-2026-042482SWBSWB-2603-A5707Janoshik2026-Q399.224.66Supplier-supplied1MARGINAL
AX-2026-042652GGPepsGGPE-2603-P8735Janoshik2026-Q399.366.96Supplier-supplied4MARGINAL
Other recent GGPeps records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042737SelankGGPE-2603-J9708Janoshik2026-Q398.409.1497.4Buyer-sourced0FAIL
AX-2026-042804SelankGGPE-2602-G2056Janoshik2026-Q398.507.97Supplier-supplied0FAIL
AX-2026-042803SelankGGPE-2602-G2056Janoshik2026-Q398.488.01Laboratory-retained1FAIL
AX-2026-042802SelankGGPE-2602-G2056Janoshik2026-Q398.747.0996.0Supplier-supplied0FAIL
AX-2026-042796SelankGGPE-2602-G2056Janoshik2026-Q398.267.5697.5Buyer-sourced0FAIL
AX-2026-042797SelankGGPE-2602-G2056Medutest2026-Q398.467.92Buyer-sourced0FAIL
AX-2026-042669CJC-1295 (no DAC)GGPE-2606-E8495Medutest2026-Q398.614.0695.5Supplier-supplied0PASS
AX-2026-042743SelankGGPE-2603-J9708Medutest2026-Q399.599.37Supplier-supplied0PASS