AssayIndex

AX-2024-004452

Hexarelin · 10 mg declared · GenScript Biotech Corporation · lot GSP-2311-C2917

FAILVERIFIED
Report ID
AX-2024-004452
Compound
Hexarelin
Compound class
Growth-hormone axis peptides
Supplier
GSP — GenScript Biotech Corporation
Batch / lot
GSP-2311-C2917
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
15 Feb 2024
Submitted
22 Feb 2024
Quarter
2024-Q1
Submitter
k.chowdhury
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, 30 min gradient, 214 nm98.79% area≥ 99.0FAIL
Total impuritiesRP-HPLC, sum of reported peaks1.21% area≤ 1.0FAIL
Largest single impurityRP-HPLC — oxidised Trp (+16 Da)0.80% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula886.4602DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)886.4592DaNOT TESTED
Mass accuracyobserved vs theoretical-1.1ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance90.10%w/wNOT TESTED
Target-compound contenttotal peptide content × purity89.01%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen12.07mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content10.744mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim107.4%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate3.84%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography5.82%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.24%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 procedureFaint haze, clearing on standingclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration6.162.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient8.79min8.92 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.860.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²66,488≥ 20,000PASS
Resolution to nearest impurityvs C-terminal free acid (+1 Da)1.14no 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.

0353170621059314125 Hexarelin8.79 min · 98.79 % 8.45 same trace · ×50 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 66,488, and skew follows the reported asymmetry factor of 0.86. 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 0.80 % impurity against a 98.79 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Hexarelin — main peak8.794,801,50098.79
2oxidised Trp (+16 Da)8.4538,8820.80+15.995
3des-methyl hexarelin (GHRP-6, −14 Da)8.318,2630.17-14.016
4des-Lys (−128 Da)8.577,7760.16-128.095
5C-terminal free acid (+1 Da)8.953,8880.08+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 886.4602 Da, computed from C47H58N12O6. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100375475575675775875975 [M+1H]1+887.47[M+2H]2+444.24 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 886.4592 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 (%)
2+444.2374444.2369-0.000562.0
1+887.4675887.4665-0.0010100.0
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 Fischer3.84
Counter-ion (acetate)ion chromatography5.82
Residual solvent + inorganic residueestimated0.24
Total peptide contentby difference90.10
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)99.4598.79divergence +0.44 pp vs batch median
Total impurities (% area)0.551.21
Largest single impurity (% area)0.250.80
Water (%)3.63.84
Counter-ion (%)not stated5.82
Peptide content (%w/w)91.690.10
Endotoxin (EU/mg)not statednot 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 (ambient, 30 d) → laboratory (courier, cold pack, 9 d) → assay.
Assay date
15 Feb 2024
Submitted to the index
22 Feb 2024
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
Section 6

Annotations 3

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.

mass_defect
Before assigning oxidised Trp (+16 Da) from retention alone, check the mass defect on the impurity peak. Plausible and implausible assignments separate cleanly and the check costs nothing.
hilic_hana
Purity 98.79 % with oxidised Trp (+16 Da) at 0.80 % nearby. Read the pair together: the purity figure and its nearest neighbour are two views of one integration decision.
hplc_ola
Flow rate is the free variable most operators never touch. Halving it on an isocratic hold across the pair is a fifteen-minute experiment with a definitive answer.
Section 7

Related records

Same batch — lot GSP-2311-C2917 n=3

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-004450GSP-2311-C2917Janoshik2024-Q199.025.03Buyer-sourced0PASS
AX-2024-004451GSP-2311-C2917Nordanalyt2024-Q199.014.00104.6Buyer-sourced0PASS
Other recent Hexarelin records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042177JEEPJEEP-2608-Y9547Janoshik2026-Q399.903.42Buyer-sourced0PASS
AX-2026-042178JEEPJEEP-2608-Y9547VendorInvestigate2026-Q399.684.03Buyer-sourced0PASS
AX-2026-043097KPKP-2604-X5990Medutest2026-Q299.552.60Laboratory-retained0PASS
AX-2026-043253CPCCPC-2511-F9455Janoshik2026-Q298.536.11Buyer-sourced0FAIL
AX-2026-043098KPKP-2604-X5990PeptideMeter2026-Q298.663.14Buyer-sourced0FAIL
AX-2026-042366HomopeptideHOMO-2602-R3080Janoshik2026-Q299.554.14Buyer-sourced0PASS
AX-2026-042365HomopeptideHOMO-2602-R3080PeptideMeter2026-Q299.664.4494.8Buyer-sourced0PASS
AX-2026-043100KPKP-2604-X5990Janoshik2026-Q298.823.5792.0Buyer-sourced0FAIL
Other recent GSP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041831SurvodutideGSP-2603-E3156Kestrel2026-Q399.915.5093.2Buyer-sourced0PASS
AX-2026-041836SurvodutideGSP-2603-E3156Janoshik2026-Q398.655.3490.3Buyer-sourced0PASS
AX-2026-041837SurvodutideGSP-2603-E3156Janoshik2026-Q398.335.37Buyer-sourced0PASS
AX-2026-041833SurvodutideGSP-2603-E3156Janoshik2026-Q398.084.9199.3Buyer-sourced0PASS
AX-2026-041832SurvodutideGSP-2603-E3156VendorInvestigate2026-Q398.015.1499.5Buyer-sourced0PASS
AX-2026-041835SurvodutideGSP-2603-E3156Nordanalyt2026-Q398.345.7489.0Buyer-sourced1MARGINAL
AX-2026-041834SurvodutideGSP-2603-E3156VendorInvestigate2026-Q397.925.95Buyer-sourced0PASS
AX-2026-041838SurvodutideGSP-2603-E3156PeptideMeter2026-Q398.305.01102.4Buyer-sourced0PASS