AssayIndex

AX-2024-005037

Humanin (HNG) · 5 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2403-N2129

FAILPURITY ONLY
Report ID
AX-2024-005037
Compound
Humanin (HNG)
Compound class
Metabolic and mitochondrial peptides
Supplier
GGPeps — Nantong Guangyuan Chemical Co., Ltd.
Batch / lot
GGPE-2403-N2129
Declared label claim
5mg
Laboratory
Nordanalyt Laboratories
Assay date
13 Apr 2024
Submitted
04 May 2024
Quarter
2024-Q2
Submitter
ar.amankwah
Sample provenance
Supplier-supplied
Section 1

Results

Measured against the index acceptance specification for the metabolic and mitochondrial 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, 35 min gradient, 214 nm99.15% area≥ 97.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.85% area≤ 2.5PASS
Largest single impurityRP-HPLC — Met sulfoxide (+16 Da)0.42% 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, duplicate4.21%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography6.84%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/1.00%NOT TESTED
Endotoxinkinetic chromogenic LAL6.88EU/mg≤ 5.0FAIL
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 calibration5.342.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient14.07min14.00 ± 0.30 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.230.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²60,124≥ 20,000PASS
Resolution to nearest impurityvs wild-type humanin (Ser14, −42 Da)0.74no 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.

01794358853827176 Humanin (HNG)14.07 min · 99.15 % 13.58 same trace · ×100 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0510152025303540 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 35 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 60,124, and skew follows the reported asymmetry factor of 1.23. 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 0.42 % impurity against a 99.15 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Humanin (HNG) — main peak14.074,818,99799.15
2Met sulfoxide (+16 Da)13.5820,4130.42+15.995
3wild-type humanin (Ser14, −42 Da)13.8913,1230.27-42.011
4deamidated (+1 Da)13.745,3460.11+0.984
5truncated (1-20)12.502,4300.05-472.245
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)99.6099.15divergence +0.38 pp vs batch median
Total impurities (% area)0.400.85
Largest single impurity (% area)not stated0.42
Water (%)not stated4.21
Counter-ion (%)not stated6.84
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)not stated6.88
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, 3 d) → assay. Submitter did not handle the vial.
Assay date
13 Apr 2024
Submitted to the index
04 May 2024
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 min gradient · high-resolution MS
Verification status
PURITY ONLY
Section 6

Annotations 5

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.

endotoxin_limit
Endotoxin burden at this level usually tracks water quality at the fill step rather than anything about the synthesis. A high-purity lot with high endotoxin is an entirely coherent result and this is one.
aib_two
Endotoxin determined but the LAL method is not stated. Kinetic chromogenic and gel-clot give different results and different sensitivity. The value cannot be interpreted without knowing which.
valley_drop
No endotoxin figure on this record, which is true of roughly three quarters of the index. It is the one measurement that cannot be inferred from any other and the one most often omitted.
bland_altman
High endotoxin 6.88 EU/mg on high-purity material vs purity suggests water quality at the fill step. If the lot was lyophilised from non-purified water, this is the expected finding.
buyer_sourced
6.88 EU/mg is elevated relative to the index median and the record shows no depyrogenation step. If this material will be reconstituted in aqueous buffer for any downstream use, that endotoxin load is a risk.
Section 7

Related records

Same batch — lot GGPE-2403-N2129 n=7

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-005032GGPE-2403-N2129PeptideMeter2024-Q299.934.1394.2Supplier-supplied2FAIL
AX-2024-005033GGPE-2403-N2129Janoshik2024-Q299.223.41103.6Supplier-supplied2FAIL
AX-2024-005034GGPE-2403-N2129Nordanalyt2024-Q299.254.66102.5Supplier-supplied1MARGINAL
AX-2024-005035GGPE-2403-N2129Janoshik2024-Q299.623.6693.4Supplier-supplied1MARGINAL
AX-2024-005036GGPE-2403-N2129PeptideMeter2024-Q299.134.2793.5Buyer-sourced1MARGINAL
AX-2024-005038GGPE-2403-N2129Janoshik2024-Q298.964.0499.2Supplier-supplied1MARGINAL
Other recent Humanin (HNG) records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041973TFCTFC-2605-U5564Janoshik2026-Q399.627.03Supplier-supplied2FAIL
AX-2026-041980TFCTFC-2605-U5564Janoshik2026-Q399.907.0188.6Supplier-supplied2MARGINAL
AX-2026-041979TFCTFC-2605-U5564Nordanalyt2026-Q399.736.64Supplier-supplied1MARGINAL
AX-2026-041981TFCTFC-2605-U5564Medutest2026-Q399.876.84Supplier-supplied1MARGINAL
AX-2026-041975TFCTFC-2605-U5564Nordanalyt2026-Q399.936.8691.5Supplier-supplied1MARGINAL
AX-2026-041977TFCTFC-2605-U5564Medutest2026-Q399.196.76103.8Supplier-supplied1MARGINAL
AX-2026-041972TFCTFC-2605-U5564Janoshik2026-Q399.486.1192.0Supplier-supplied1MARGINAL
AX-2026-041974TFCTFC-2605-U5564Janoshik2026-Q399.936.3196.6Supplier-supplied1MARGINAL
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-2026-042648Melanotan IIGGPE-2603-P8735Janoshik2026-Q399.106.97Supplier-supplied4MARGINAL
AX-2026-042797SelankGGPE-2602-G2056Medutest2026-Q398.467.92Buyer-sourced0FAIL
AX-2026-042669CJC-1295 (no DAC)GGPE-2606-E8495Medutest2026-Q398.614.0695.5Supplier-supplied0PASS