AssayIndex

AX-2026-041893

Ipamorelin · 2 mg declared · SinoPep Biotechnology (Changzhou) Co., Ltd. · lot SNP-2602-B3833

MARGINALVERIFIED
Report ID
AX-2026-041893
Compound
Ipamorelin
Compound class
Growth-hormone axis peptides
Supplier
SinoPep — SinoPep Biotechnology (Changzhou) Co., Ltd.
Batch / lot
SNP-2602-B3833
Declared label claim
2mg
Laboratory
Janoshik Analytical
Assay date
26 Jul 2026
Submitted
14 Aug 2026
Quarter
2026-Q3
Submitter
s.broberg
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 nm99.80% area≥ 99.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.20% area≤ 1.0PASS
Largest single impurityRP-HPLC — Aib-deletion sequence (−85 Da)0.12% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula711.3856DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)711.3874DaNOT TESTED
Mass accuracyobserved vs theoretical+2.6ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance89.86%w/wNOT TESTED
Target-compound contenttotal peptide content × purity89.68%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen2.24mg2 mg declaredNOT TESTED
Recovered target peptidegross fill × target content2.009mg2 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim100.4%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.62%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography4.95%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.57%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 backgroundOff-white lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear after 90 s gentle swirling, no particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.332.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient8.27min8.24 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.990.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²48,902≥ 20,000PASS
Resolution to nearest impurityvs des-Lys (−128 Da)1.43no 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.

031056209931412419 Ipamorelin8.27 min · 99.80 % 7.99 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 48,902, and skew follows the reported asymmetry factor of 0.99. 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 0.12 % impurity against a 99.80 % 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 peak8.274,850,58999.80
2Aib-deletion sequence (−85 Da)7.995,8320.12-85.053
3oxidised Trp (+16 Da)7.932,4300.05+15.995
4des-Lys (−128 Da)8.051,4580.03-128.095
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 711.3874 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+356.7001356.70100.000957.5
1+712.3929712.39470.0018100.0
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 Fischer4.62
Counter-ion (acetate)ion chromatography4.95
Residual solvent + inorganic residueestimated0.57
Total peptide contentby difference89.86
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)99.9099.80divergence -0.03 pp vs batch median
Total impurities (% area)0.100.20
Largest single impurity (% area)0.050.12
Water (%)not stated4.62
Counter-ion (%)not stated4.95
Peptide content (%w/w)not stated89.86
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 (17 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date
26 Jul 2026
Submitted to the index
14 Aug 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
Section 6

Annotations 4

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.

prep_hplc_cut
0.20 % 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.
c18_2p6
Column chemistry flatters or punishes a figure like this. A core-shell column at this gradient resolves the close-eluting family that a fully porous 5 µm bed merges, so 99.80 % here is a harder number than the same figure from a coarser column.
bland_altman
Where two laboratories tested the same retail lot, the paired difference is a clean estimate of inter-lab bias with no selection term in it at all. Those pairs are the backbone of the agreement analysis.
triptorelin_dtrp
Enantiomeric and epimeric impurities are the extreme case: identical mass, near-identical retention, and separable only by a method chosen for the purpose.
Section 7

Related records

Same batch — lot SNP-2602-B3833 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041891SNP-2602-B3833Janoshik2026-Q399.935.11Buyer-sourced1MARGINAL
AX-2026-041892SNP-2602-B3833Nordanalyt2026-Q399.735.3588.9Buyer-sourced2MARGINAL
AX-2026-041894SNP-2602-B3833Janoshik2026-Q399.844.8197.4Laboratory-retained1MARGINAL
AX-2026-041895SNP-2602-B3833Janoshik2026-Q399.934.72105.9Buyer-sourced1MARGINAL
AX-2026-041896SNP-2602-B3833Janoshik2026-Q399.935.2196.9Supplier-supplied1MARGINAL
AX-2026-041897SNP-2602-B3833Janoshik2026-Q399.775.12Buyer-sourced1MARGINAL
AX-2026-041898SNP-2602-B3833Nordanalyt2026-Q399.934.5496.0Buyer-sourced1MARGINAL
AX-2026-041899SNP-2602-B3833PeptideMeter2026-Q399.934.9690.1Buyer-sourced1MARGINAL
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 SinoPep records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041867CJC-1295 with DACSNP-2607-C3886Janoshik2026-Q399.245.12Laboratory-retained1FAIL
AX-2026-041913IpamorelinSNP-2606-L4478PeptideMeter2026-Q398.885.28Buyer-sourced0FAIL
AX-2026-041914IpamorelinSNP-2606-L4478Janoshik2026-Q399.145.49Buyer-sourced0PASS
AX-2026-041909IpamorelinSNP-2606-L4478PeptideMeter2026-Q399.005.4889.5Buyer-sourced1MARGINAL
AX-2026-041895IpamorelinSNP-2602-B3833Janoshik2026-Q399.934.72105.9Buyer-sourced1MARGINAL
AX-2026-041930IGF-1 LR3SNP-2606-D4620Medutest2026-Q398.545.3793.8Buyer-sourced0PASS
AX-2026-041898IpamorelinSNP-2602-B3833Nordanalyt2026-Q399.934.5496.0Buyer-sourced1MARGINAL
AX-2026-041931IGF-1 LR3SNP-2606-D4620PeptideMeter2026-Q397.935.1993.4Buyer-sourced0PASS