AssayIndex

AX-2026-043323

Ipamorelin · 5 mg declared · Chinese Peptide Company Co., Ltd. · lot CPC-2508-Y1913

FAILPURITY ONLY
Report ID
AX-2026-043323
Compound
Ipamorelin
Compound class
Growth-hormone axis peptides
Supplier
CPC — Chinese Peptide Company Co., Ltd.
Batch / lot
CPC-2508-Y1913
Declared label claim
5mg
Laboratory
Janoshik Analytical
Assay date
21 Mar 2026
Submitted
24 Mar 2026
Quarter
2026-Q1
Submitter
Contributor #V-2091
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 nm98.25% area≥ 99.0FAIL
Total impuritiesRP-HPLC, sum of reported peaks1.75% area≤ 1.0FAIL
Largest single impurityRP-HPLC — oxidised Trp (+16 Da)1.17% area≤ 1.00FAIL
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate4.90%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography4.98%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.60%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 after 90 s gentle swirling, no particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration6.362.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient8.41min8.24 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.890.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²56,465≥ 20,000PASS
Resolution to nearest impurityvs [D-Trp]-epimer0.83no 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.

0338367651014813530 Ipamorelin8.41 min · 98.25 % 8.07 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 56,465, and skew follows the reported asymmetry factor of 0.89. 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 1.17 % impurity against a 98.25 % 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 peak8.414,775,25598.25
2oxidised Trp (+16 Da)8.0756,8661.17+15.995
3Aib-deletion sequence (−85 Da)8.1316,5250.34-85.053
4des-Lys (−128 Da)8.196,8040.14-128.095
5[D-Trp]-epimer8.292,9160.060.000
6C-terminal free acid (+1 Da)8.591,9440.04+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 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)98.598.25divergence +0.39 pp vs batch median
Total impurities (% area)not stated1.75
Largest single impurity (% area)not stated1.17
Water (%)4.94.90
Counter-ion (%)not stated4.98
Peptide content (%w/w)90.3not 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
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Retail purchase → submitter (ambient, 21 d) → laboratory (courier, cold pack, 5 d) → assay.
Assay date
21 Mar 2026
Submitted to the index
24 Mar 2026
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.

wide_iqr
98.25 % on Ipamorelin is below the index specification for the class. The interesting part is the distribution: oxidised Trp (+16 Da) at 1.17 % is doing most of the work, and that species is a synthesis artefact rather than a degradation product. This is a process observation about lot CPC-2508-Y1913, not a storage one.
digit_preference
Rule AX-R04 carries the lowest severity in the rule set for a reason. It is a finding about how a number was written down.
lot_traceability
Purity 98.25 %, water 4.90 %, counter-ion 4.98 % acetate, mass balance closed, provenance independent. There is nothing outstanding on this record.
Section 7

Related records

Same batch — lot CPC-2508-Y1913 n=5

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043321CPC-2508-Y1913Kestrel2026-Q198.525.49Buyer-sourced1FAIL
AX-2026-043322CPC-2508-Y1913PeptideMeter2026-Q198.005.65Buyer-sourced1FAIL
AX-2026-043324CPC-2508-Y1913Janoshik2026-Q198.105.57Buyer-sourced1FAIL
AX-2026-043325CPC-2508-Y1913PeptideMeter2026-Q198.115.61Buyer-sourced1FAIL
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 CPC records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043319BPC-157CPC-2602-W1610Medutest2026-Q398.822.88103.5Buyer-sourced2MARGINAL
AX-2026-043295LiraglutideCPC-2602-G9942Janoshik2026-Q397.345.17106.3Buyer-sourced0FAIL
AX-2026-043288TirzepatideCPC-2607-L1516Janoshik2026-Q396.895.11101.1Laboratory-retained0FAIL
AX-2026-043327N-Acetyl Semax AmideCPC-2602-D1905Nordanalyt2026-Q399.055.6790.6Buyer-sourced1FAIL
AX-2026-043328N-Acetyl Semax AmideCPC-2602-D1905Janoshik2026-Q399.496.83100.9Supplier-supplied0PASS
AX-2026-043257L-CarnosineCPC-2603-G9615VendorInvestigate2026-Q398.2010.41102.2Buyer-sourced0FAIL
AX-2026-043297LiraglutideCPC-2602-G9942Janoshik2026-Q397.014.95103.5Buyer-sourced0FAIL
AX-2026-043331N-Acetyl Semax AmideCPC-2602-D1905Janoshik2026-Q399.466.22Supplier-supplied0PASS