AssayIndex

AX-2025-020937

Ipamorelin · 2 mg declared · Chinese Peptide Company Co., Ltd. · lot CPC-2503-J2830

FAILIDENTITY CONSISTENT
Report ID
AX-2025-020937
Compound
Ipamorelin
Compound class
Growth-hormone axis peptides
Supplier
CPC — Chinese Peptide Company Co., Ltd.
Batch / lot
CPC-2503-J2830
Declared label claim
2mg
Laboratory
Janoshik Analytical
Assay date
27 Feb 2025
Submitted
02 Mar 2025
Quarter
2025-Q1
Submitter
ha.varga
Sample provenance
Supplier-supplied
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 nm98.07% area≥ 99.0FAIL
Total impuritiesRP-HPLC, sum of reported peaks1.93% area≤ 1.0FAIL
Largest single impurityRP-HPLC — [D-Trp]-epimer1.03% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula711.3856DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)711.3878DaNOT TESTED
Mass accuracyobserved vs theoretical+3.1ppm± 15PASS
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate6.78%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography7.72%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.96%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, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.492.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient8.24min8.24 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.070.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²52,875≥ 20,000PASS
Resolution to nearest impurityvs [D-Trp]-epimer0.82no 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.

030616122918312244 Ipamorelin8.24 min · 98.07 % 8.12 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 52,875, and skew follows the reported asymmetry factor of 1.07. 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 1.03 % impurity against a 98.07 % 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 peak8.244,766,50698.07
2[D-Trp]-epimer8.1250,0611.030.000
3oxidised Trp (+16 Da)7.9024,7880.51+15.995
4des-Lys (−128 Da)8.0211,1790.23-128.095
5Aib-deletion sequence (−85 Da)7.964,3740.09-85.053
6C-terminal free acid (+1 Da)8.423,4020.07+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 711.3856 Da, computed from C38H49N9O5. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100300375450525600675750 [M+1H]1+712.40[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 711.3878 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+356.7001356.70120.001150.4
1+712.3929712.39510.0022100.0
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.

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)98.098.07divergence +0.11 pp vs batch median
Total impurities (% area)2.001.93
Largest single impurity (% area)0.801.03
Water (%)not stated6.78
Counter-ion (%)not stated7.72
Peptide content (%w/w)98.3not determined
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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 6 d) → assay. Submitter did not handle the vial.
Assay date
27 Feb 2025
Submitted to the index
02 Mar 2025
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
IDENTITY CONSISTENT
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 CPC-2503-J2830 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020938CPC-2503-J2830Nordanalyt2025-Q197.946.33Supplier-supplied2FAIL
AX-2025-020939CPC-2503-J2830Janoshik2025-Q197.866.79Supplier-supplied2FAIL
AX-2025-020940CPC-2503-J2830PeptideMeter2025-Q197.516.33Buyer-sourced2FAIL
AX-2025-020941CPC-2503-J2830Janoshik2025-Q197.346.1798.1Buyer-sourced2FAIL
AX-2025-020942CPC-2503-J2830Medutest2025-Q198.136.81Supplier-supplied2FAIL
AX-2025-020943CPC-2503-J2830PeptideMeter2025-Q197.716.50102.5Supplier-supplied2FAIL
AX-2025-020944CPC-2503-J2830Janoshik2025-Q197.896.60102.0Supplier-supplied2FAIL
AX-2025-020945CPC-2503-J2830Janoshik2025-Q198.687.09Supplier-supplied3FAIL
Other recent Ipamorelin records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042181HomopeptideHOMO-2608-A9045Janoshik2026-Q399.784.79Supplier-supplied1MARGINAL
AX-2026-042180HomopeptideHOMO-2608-A9045Janoshik2026-Q399.394.74105.5Supplier-supplied1MARGINAL
AX-2026-042184HomopeptideHOMO-2608-A9045Kestrel2026-Q399.274.79103.2Supplier-supplied1MARGINAL
AX-2026-041427QYBQYB-2605-H4298Janoshik2026-Q399.934.12Supplier-supplied0PASS
AX-2026-042183HomopeptideHOMO-2608-A9045VendorInvestigate2026-Q399.384.97Buyer-sourced1MARGINAL
AX-2026-043090KPKP-2606-D5887Janoshik2026-Q398.183.07101.2Laboratory-retained1FAIL
AX-2026-042191HomopeptideHOMO-2608-A9045Medutest2026-Q399.675.00104.6Supplier-supplied1MARGINAL
AX-2026-041425QYBQYB-2605-H4298Janoshik2026-Q399.933.6593.4Supplier-supplied0PASS
Other recent CPC records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043368N-Acetyl Semax AmideCPC-2602-D2941Medutest2026-Q398.796.05102.1Supplier-supplied0PASS
AX-2026-043335LiraglutideCPC-2602-G1978Janoshik2026-Q397.294.91Laboratory-retained1FAIL
AX-2026-043283L-CarnosineCPC-2603-G1651Medutest2026-Q398.1010.1291.8Supplier-supplied1FAIL
AX-2026-043365BPC-157CPC-2602-W2646Medutest2026-Q398.562.80Supplier-supplied1MARGINAL
AX-2026-043332LiraglutideCPC-2602-G1978Janoshik2026-Q397.164.8891.3Supplier-supplied1FAIL
AX-2026-043289L-CarnosineCPC-2603-G1651Janoshik2026-Q398.0110.52Buyer-sourced1FAIL
AX-2026-043287L-CarnosineCPC-2603-G1651Janoshik2026-Q398.359.8993.2Supplier-supplied2FAIL
AX-2026-043367N-Acetyl Semax AmideCPC-2602-D2941Nordanalyt2026-Q399.396.1692.4Supplier-supplied0PASS