AssayIndex

AX-2025-019922

Ipamorelin · 10 mg declared · Hubei Jianxiang Bioscience Co., Ltd. · lot HJ-2504-X6056

PASSPURITY ONLY
Report ID
AX-2025-019922
Compound
Ipamorelin
Compound class
Growth-hormone axis peptides
Supplier
HJ — Hubei Jianxiang Bioscience Co., Ltd.
Batch / lot
HJ-2504-X6056
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
01 Aug 2025
Submitted
10 Aug 2025
Quarter
2025-Q3
Submitter
g.petrov
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 nm99.73% area≥ 99.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.27% area≤ 1.0PASS
Largest single impurityRP-HPLC — C-terminal free acid (+1 Da)0.13% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance86.28%w/wNOT TESTED
Target-compound contenttotal peptide content × purity86.05%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen12.49mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content10.748mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim107.5%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate6.85%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography6.31%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.56%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 cake, partially collapsedwhite to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear after 90 s gentle swirling, no particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.812.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient8.36min8.24 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.060.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²69,099≥ 20,000PASS
Resolution to nearest impurityvs [D-Trp]-epimer0.92no 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.

0352470481057314097 Ipamorelin8.36 min · 99.73 % 8.54 same trace · ×200 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 69,099, and skew follows the reported asymmetry factor of 1.06. 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 0.13 % impurity against a 99.73 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Ipamorelin — main peak8.364,847,18799.73
2C-terminal free acid (+1 Da)8.546,3180.13+0.984
3[D-Trp]-epimer8.243,4020.070.000
4des-Lys (−128 Da)8.141,9440.04-128.095
5oxidised Trp (+16 Da)8.021,4580.03+15.995
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.

ComponentDetermination%w/w of cake
WaterKarl Fischer6.85
Counter-ion (acetate)ion chromatography6.31
Residual solvent + inorganic residueestimated0.56
Total peptide contentby difference86.28
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)99.6999.73divergence +0.09 pp vs batch median
Total impurities (% area)0.310.27
Largest single impurity (% area)0.120.13
Water (%)4.96.85
Counter-ion (%)not stated6.31
Peptide content (%w/w)not stated86.28
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 → third-party forwarder (13 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date
01 Aug 2025
Submitted to the index
10 Aug 2025
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
PURITY ONLY
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.

sig_figs
Two decimal places on 99.73 % implies repeatability better than 0.01 pp, which no laboratory here claims. The number is sound; the printed precision is more than the method carries.
Index data team

Two decimal places are retained because the source reports carry them and truncating would discard information where a laboratory genuinely reports it. The uncertainty budget on /methods/uncertainty-budget/ is the right thing to read alongside any purity figure on this site.

prep_hplc_cut
0.27 % total impurities on Ipamorelin means the preparative fraction was cut narrow. That trades yield for purity, and the trade was made in the buyer's favour on this lot.
storage_stated
Purity 99.73 %, water 6.85 %, counter-ion 6.31 % acetate, mass balance closed, provenance independent. There is nothing outstanding on this record.
Section 7

Related records

Same batch — lot HJ-2504-X6056 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-019915HJ-2504-X6056Nordanalyt2025-Q399.586.6991.4Buyer-sourced0PASS
AX-2025-019916HJ-2504-X6056Janoshik2025-Q399.827.43Buyer-sourced0PASS
AX-2025-019917HJ-2504-X6056VendorInvestigate2025-Q399.166.66Buyer-sourced0PASS
AX-2025-019918HJ-2504-X6056Janoshik2025-Q399.597.05Buyer-sourced0PASS
AX-2025-019919HJ-2504-X6056Janoshik2025-Q399.806.3791.1Buyer-sourced0PASS
AX-2025-019920HJ-2504-X6056Janoshik2025-Q399.526.3788.5Buyer-sourced1MARGINAL
AX-2025-019921HJ-2504-X6056Medutest2025-Q399.936.2993.6Buyer-sourced1FAIL
AX-2025-019923HJ-2504-X6056Janoshik2025-Q399.606.8091.8Buyer-sourced0PASS
Other recent Ipamorelin records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041377QYBQYB-2605-H3558Nordanalyt2026-Q399.934.35Buyer-sourced0PASS
AX-2026-041913SinoPepSNP-2606-L4478PeptideMeter2026-Q398.885.28Buyer-sourced0FAIL
AX-2026-041914SinoPepSNP-2606-L4478Janoshik2026-Q399.145.49Buyer-sourced0PASS
AX-2026-041909SinoPepSNP-2606-L4478PeptideMeter2026-Q399.005.4889.5Buyer-sourced1MARGINAL
AX-2026-041895SinoPepSNP-2602-B3833Janoshik2026-Q399.934.72105.9Buyer-sourced1MARGINAL
AX-2026-041898SinoPepSNP-2602-B3833Nordanalyt2026-Q399.934.5496.0Buyer-sourced1MARGINAL
AX-2026-041899SinoPepSNP-2602-B3833PeptideMeter2026-Q399.934.9690.1Buyer-sourced1MARGINAL
AX-2026-041891SinoPepSNP-2602-B3833Janoshik2026-Q399.935.11Buyer-sourced1MARGINAL
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