AssayIndex

AX-2025-020129

Ipamorelin · 10 mg declared · Shanghai ERP Biotechnology Co., Ltd. · lot ERP-2505-U8938

MARGINALPURITY ONLY
Report ID
AX-2025-020129
Compound
Ipamorelin
Compound class
Growth-hormone axis peptides
Supplier
ERP — Shanghai ERP Biotechnology Co., Ltd.
Batch / lot
ERP-2505-U8938
Declared label claim
10mg
Laboratory
PeptideMeter
Assay date
26 Oct 2025
Submitted
14 Nov 2025
Quarter
2025-Q4
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, 28 min gradient, 214 nm99.47% area≥ 99.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.53% area≤ 1.0PASS
Largest single impurityRP-HPLC — des-Lys (−128 Da)0.34% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance88.41%w/wNOT TESTED
Target-compound contenttotal peptide content × purity87.94%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen10.71mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content9.418mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim94.2%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate3.84%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography6.78%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.97%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, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.912.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient7.66min7.73 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.900.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²69,770≥ 20,000PASS
Resolution to nearest impurityvs [D-Trp]-epimer0.94no 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.

0417983591253816718 Ipamorelin7.66 min · 99.47 % 7.45 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 051015202530 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 28 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 69,770, and skew follows the reported asymmetry factor of 0.90. 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 0.34 % impurity against a 99.47 % 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 peak7.664,834,55099.47
2des-Lys (−128 Da)7.4516,5250.34-128.095
3oxidised Trp (+16 Da)7.344,8600.10+15.995
4[D-Trp]-epimer7.552,9160.060.000
5Aib-deletion sequence (−85 Da)7.401,4580.03-85.053
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 Fischer3.84
Counter-ion (acetate)ion chromatography6.78
Residual solvent + inorganic residueestimated0.97
Total peptide contentby difference88.41
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)99.9099.47divergence +0.28 pp vs batch median
Total impurities (% area)not stated0.53
Largest single impurity (% area)not stated0.34
Water (%)1.73.84
Counter-ion (%)2.36.78
Peptide content (%w/w)95.488.41
Endotoxin (EU/mg)not statednot determined
Method stated on certificateNOno method section — the result cannot be reconciled against any other
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
Domestic warehouse despatch → submitter (2–8 °C, 11 d) → laboratory (courier, cold pack, 8 d) → assay.
Assay date
26 Oct 2025
Submitted to the index
14 Nov 2025
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 min gradient · high-resolution MS
Verification status
PURITY ONLY
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.

valley_drop
Largest single impurity is des-Lys (−128 Da) at 0.34 % area, and it is the only named peak above 0.1 %. The integration is unambiguous and 99.47 % can be taken at face value.
lambda_214
At 214 nm the amide bond dominates the response, so a peptide impurity is seen roughly in proportion to its size. 99.47 % on this detection is the conservative reading; a 280 nm trace would flatter it.
selection_bias
Provenance handles supplier selection. It does not handle submitter selection, which is the larger confounder and the one the index cannot measure.
aib_two
On the multi-Aib analogues the des-Aib species elutes a third of a minute early and routinely arrives as a leading shoulder rather than a peak. That is a compound property and every laboratory faces it.
Section 7

Related records

Same batch — lot ERP-2505-U8938 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020124ERP-2505-U8938Janoshik2025-Q499.643.75Buyer-sourced2MARGINAL
AX-2025-020125ERP-2505-U8938Janoshik2025-Q499.613.79Buyer-sourced1MARGINAL
AX-2025-020126ERP-2505-U8938Medutest2025-Q499.624.09100.7Buyer-sourced1MARGINAL
AX-2025-020127ERP-2505-U8938PeptideMeter2025-Q499.934.13107.5Buyer-sourced1MARGINAL
AX-2025-020128ERP-2505-U8938Medutest2025-Q499.933.8589.0Buyer-sourced2MARGINAL
AX-2025-020130ERP-2505-U8938PeptideMeter2025-Q499.554.52101.6Buyer-sourced1MARGINAL
AX-2025-020131ERP-2505-U8938PeptideMeter2025-Q499.903.81Buyer-sourced1MARGINAL
AX-2026-042690ERP-2505-U8938Janoshik2025-Q499.514.34Buyer-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 ERP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042706SurvodutideERP-2605-E9865PeptideMeter2026-Q398.385.33103.5Buyer-sourced0PASS
AX-2026-042704TesamorelinERP-2604-W9463Janoshik2026-Q399.024.08Buyer-sourced1MARGINAL
AX-2026-042705SurvodutideERP-2605-E9865Janoshik2026-Q398.245.3692.3Buyer-sourced0PASS
AX-2026-042708GHK-CuERP-2601-F9816Nordanalyt2026-Q298.883.8791.5Buyer-sourced1MARGINAL
AX-2026-042694LiraglutideERP-2601-P8985Kestrel2026-Q299.254.35107.3Buyer-sourced1MARGINAL
AX-2026-042707GHK-CuERP-2601-F9816Janoshik2026-Q298.534.7096.3Buyer-sourced1MARGINAL
AX-2026-042711GHK-CuERP-2601-F9816Kestrel2026-Q298.533.8489.7Laboratory-retained2MARGINAL
AX-2026-042722TirzepatideERP-2512-T9616Medutest2026-Q299.182.07Buyer-sourced1MARGINAL