AssayIndex

AX-2025-020128

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

MARGINALPURITY ONLY
Report ID
AX-2025-020128
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
Medutest
Assay date
29 Nov 2025
Submitted
01 Dec 2025
Quarter
2025-Q4
Submitter
an.pereira
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, 25 min gradient, 214 nm99.93% area≥ 99.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.07% area≤ 1.0PASS
Largest single impurityRP-HPLC — des-Lys (−128 Da)0.04% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance88.18%w/wNOT TESTED
Target-compound contenttotal peptide content × purity88.12%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen10.10mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content8.900mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim89.0%90.0 – 110.0FAIL
Water contentKarl Fischer, coulometric, duplicate3.85%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography7.19%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.78%NOT TESTED
Endotoxinkinetic chromogenic LAL0.13EU/mg≤ 5.0PASS
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite to pale-yellow 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 calibration5.882.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient6.86min6.98 ± 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)²63,928≥ 20,000PASS
Resolution to nearest impurityvs C-terminal free acid (+1 Da)1.35no 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.

0428585701285517140 Ipamorelin6.86 min · 99.93 % 6.68 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0481216202428 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 25 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 63,928, 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 0.04 % impurity against a 99.93 % 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 peak6.864,856,90899.93
2des-Lys (−128 Da)6.681,9440.04-128.095
3C-terminal free acid (+1 Da)7.011,4580.03+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.

ComponentDetermination%w/w of cake
WaterKarl Fischer3.85
Counter-ion (acetate)ion chromatography7.19
Residual solvent + inorganic residueestimated0.78
Total peptide contentby difference88.18
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)99.9099.93divergence +0.28 pp vs batch median
Total impurities (% area)not stated0.07
Largest single impurity (% area)not stated0.04
Water (%)1.73.85
Counter-ion (%)2.37.19
Peptide content (%w/w)95.488.18
Endotoxin (EU/mg)not stated0.13
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
Retail purchase → submitter (−20 °C, 29 d) → laboratory (courier, dry ice, 3 d) → assay.
Assay date
29 Nov 2025
Submitted to the index
01 Dec 2025
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-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.

peak_integrator
99.93 % is normalised area, so it is silent on how much peptide is in the vial. Content and water are the numbers that answer that, and both are on this record. Purity is the good news; content is the actionable news.
desiccant_note
The packaging as received is part of the evidence on a retail purchase. Whether a desiccant was in the box is a fact about ordinary shipments, not about sample shipments.
hilic_hana
Orthogonal selectivity solves what more of the same selectivity does not. HILIC on a pair that co-elutes on C18 frequently resolves it outright.
kf_titrand
The index re-derives recovered mass from gross fill and target content on every record, and the build check re-derives it again from the published CSV. 8.90 mg is arithmetic, not a claim.
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-2025-020129ERP-2505-U8938PeptideMeter2025-Q499.473.8494.2Buyer-sourced1MARGINAL
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