AssayIndex

AX-2025-019915

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

PASSVERIFIED
Report ID
AX-2025-019915
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
Nordanalyt Laboratories
Assay date
07 Jul 2025
Submitted
31 Jul 2025
Quarter
2025-Q3
Submitter
k.castellanos
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, 35 min gradient, 214 nm99.58% area≥ 99.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.42% area≤ 1.0PASS
Largest single impurityRP-HPLC — oxidised Trp (+16 Da)0.25% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula711.3856DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)711.3848DaNOT TESTED
Mass accuracyobserved vs theoretical-1.1ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance86.14%w/wNOT TESTED
Target-compound contenttotal peptide content × purity85.78%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen10.66mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content9.144mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim91.4%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate6.69%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography6.83%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.34%NOT TESTED
Endotoxinkinetic chromogenic LAL1.05EU/mg≤ 5.0PASS
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 calibration5.232.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient9.43min9.50 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.090.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²67,736≥ 20,000PASS
Resolution to nearest impurityvs C-terminal free acid (+1 Da)1.41no 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.

030446089913312177 Ipamorelin9.43 min · 99.58 % 9.03 same trace · ×200 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 67,736, and skew follows the reported asymmetry factor of 1.09. 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 0.25 % impurity against a 99.58 % 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 peak9.434,839,89799.58
2oxidised Trp (+16 Da)9.0312,1510.25+15.995
3C-terminal free acid (+1 Da)9.645,3460.11+0.984
4Aib-deletion sequence (−85 Da)9.101,9440.04-85.053
5des-Lys (−128 Da)9.179720.02-128.095
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 711.3856 Da, computed from C38H49N9O5. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100300375450525600675750 [M+1H]1+712.39[M+2H]2+356.70 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 711.3848 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+356.7001356.6997-0.000453.1
1+712.3929712.3921-0.0008100.0
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 Fischer6.69
Counter-ion (acetate)ion chromatography6.83
Residual solvent + inorganic residueestimated0.34
Total peptide contentby difference86.14
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)99.6999.58divergence +0.09 pp vs batch median
Total impurities (% area)0.310.42
Largest single impurity (% area)0.120.25
Water (%)4.96.69
Counter-ion (%)not stated6.83
Peptide content (%w/w)not stated86.14
Endotoxin (EU/mg)not stated1.05
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, 11 d) → laboratory (hand-carried, 9 d) → assay.
Assay date
07 Jul 2025
Submitted to the index
31 Jul 2025
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 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.

des_gly
At 99.58 % the deletion-sequence family is at or below the reporting threshold. On a sequence with a hindered coupling that is a statement about coupling efficiency, and a good one.
tbu_residual
Residual side-chain protection at +56 Da is the classic silent passenger on a high-purity trace. Nothing at that offset above threshold on this record.
ms_confirm
-1.1 ppm at this mass is a clean identity confirmation. With retention at 9.43 min, Ipamorelin is established as the species measured. Note what it does not exclude: a mass-identical diastereomer, which no mass measurement of any resolution can.
Section 7

Related records

Same batch — lot HJ-2504-X6056 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
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-2025-019922HJ-2504-X6056Janoshik2025-Q399.736.85107.5Buyer-sourced0PASS
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