AssayIndex

AX-2026-042364

Sermorelin · 10 mg declared · Hubei Jianxiang Bioscience Co., Ltd. · lot HJ-2605-A4196

FAILVERIFIED
Report ID
AX-2026-042364
Compound
Sermorelin
Compound class
Growth-hormone axis peptides
Supplier
HJ — Hubei Jianxiang Bioscience Co., Ltd.
Batch / lot
HJ-2605-A4196
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
01 May 2026
Submitted
17 May 2026
Quarter
2026-Q2
Submitter
a.wojcik
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 nm98.37% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks1.63% area≤ 2.0PASS
Largest single impurityRP-HPLC — aspartimide (−18 Da)0.85% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula3355.7245DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)3355.6158DaNOT TESTED
Mass accuracyobserved vs theoretical-32.4ppm± 15FAIL
Total peptide contentby difference from the gravimetric mass balance89.22%w/wNOT TESTED
Target-compound contenttotal peptide content × purity87.77%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen11.06mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content9.707mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim97.1%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.90%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography4.73%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.15%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, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.482.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient12.36min12.42 ± 0.30 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.910.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²70,802≥ 20,000PASS
Resolution to nearest impurityvs deamidated Asn8 (+1 Da)1.58no 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.

025675134770110268 Sermorelin12.36 min · 98.37 % 12.72 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 70,802, and skew follows the reported asymmetry factor of 0.91. 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 0.85 % impurity against a 98.37 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Sermorelin — main peak12.364,781,08798.37
2aspartimide (−18 Da)12.7241,3130.85-18.011
3des-Tyr1 (−163 Da)11.8416,5250.34-163.063
4truncated (1-25)11.3211,1790.23-455.248
5deamidated Asn8 (+1 Da)12.0610,2070.21+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 3355.7245 Da, computed from C149H246N44O42. All ppm figures on this site are against monoisotopic values — see why that matters.

02550751005507751000122514501675 [M+3H]3+1119.55[M+2H]2+1678.82[M+4H]4+839.91 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 3355.6158 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+672.1522672.1304-0.02187.8
4+839.9384839.9112-0.027251.5
3+1119.58211119.5459-0.0362100.0
2+1678.86951678.8152-0.054355.6
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 Fischer5.90
Counter-ion (acetate)ion chromatography4.73
Residual solvent + inorganic residueestimated0.15
Total peptide contentby difference89.22
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)99.1398.37divergence +0.05 pp vs batch median
Total impurities (% area)0.871.63
Largest single impurity (% area)0.580.85
Water (%)4.55.90
Counter-ion (%)not stated4.73
Peptide content (%w/w)not stated89.22
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 (−20 °C, 12 d) → laboratory (courier, dry ice, 6 d) → assay.
Assay date
01 May 2026
Submitted to the index
17 May 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
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 HJ-2605-A4196 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042358HJ-2605-A4196Medutest2026-Q299.205.83Supplier-supplied0PASS
AX-2026-042359HJ-2605-A4196Kestrel2026-Q299.375.63Supplier-supplied1MARGINAL
AX-2026-042360HJ-2605-A4196Janoshik2026-Q298.865.7390.6Supplier-supplied0PASS
AX-2026-042361HJ-2605-A4196Medutest2026-Q298.935.4389.8Supplier-supplied1MARGINAL
AX-2026-042362HJ-2605-A4196PeptideMeter2026-Q298.935.80Supplier-supplied0PASS
AX-2026-042363HJ-2605-A4196Nordanalyt2026-Q299.215.8996.9Supplier-supplied0PASS
AX-2026-042365HJ-2605-A4196Janoshik2026-Q299.565.6189.6Supplier-supplied1MARGINAL
AX-2026-042366HJ-2605-A4196Janoshik2026-Q299.085.25Supplier-supplied0PASS
Other recent Sermorelin records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042057TFCTFC-2605-Y6440Janoshik2026-Q398.683.9498.3Supplier-supplied0PASS
AX-2026-043421WXTWXT-2608-P4867Janoshik2026-Q398.153.09Supplier-supplied0PASS
AX-2026-043420WXTWXT-2608-P4867Medutest2026-Q398.623.0796.4Supplier-supplied0PASS
AX-2026-043423WXTWXT-2608-P4867Janoshik2026-Q398.283.8698.5Buyer-sourced0PASS
AX-2026-042058TFCTFC-2605-Y6440Nordanalyt2026-Q398.713.69107.1Supplier-supplied0PASS
AX-2026-043422WXTWXT-2608-P4867Medutest2026-Q398.353.59Supplier-supplied1MARGINAL
AX-2026-043418WXTWXT-2608-P4867Janoshik2026-Q398.472.8889.7Supplier-supplied1MARGINAL
AX-2026-042060TFCTFC-2605-Y6440Nordanalyt2026-Q398.313.3092.4Supplier-supplied0PASS
Other recent HJ records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042368SemaxHJ-2603-V4363Nordanalyt2026-Q399.177.26106.3Supplier-supplied1MARGINAL
AX-2026-042347SemaglutideHJ-2608-C3931VendorInvestigate2026-Q398.803.41100.2Buyer-sourced1MARGINAL
AX-2026-042367SemaxHJ-2603-V4363Kestrel2026-Q399.106.7893.9Supplier-supplied1MARGINAL
AX-2026-042348SemaglutideHJ-2608-C3931Nordanalyt2026-Q399.524.19Supplier-supplied1MARGINAL
AX-2026-042290GHRP-6HJ-2603-R2258Janoshik2026-Q399.713.05Supplier-supplied2MARGINAL
AX-2026-042287GHRP-6HJ-2603-R2258VendorInvestigate2026-Q398.792.4390.9Buyer-sourced2FAIL
AX-2026-042288GHRP-6HJ-2603-R2258Kestrel2026-Q399.932.8292.8Supplier-supplied2MARGINAL
AX-2026-042346SemaglutideHJ-2608-C3931VendorInvestigate2026-Q399.403.48Buyer-sourced1MARGINAL