AssayIndex

AX-2025-019296

Ipamorelin · 5 mg declared · AmbioPharm, Inc. · lot AMB-2505-J6078

PASSPURITY ONLY
Report ID
AX-2025-019296
Compound
Ipamorelin
Compound class
Growth-hormone axis peptides
Supplier
AMB — AmbioPharm, Inc.
Batch / lot
AMB-2505-J6078
Declared label claim
5mg
Laboratory
PeptideMeter
Assay date
03 Sep 2025
Submitted
04 Sep 2025
Quarter
2025-Q3
Submitter
au.marchand
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 nm99.82% area≥ 99.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.18% area≤ 1.0PASS
Largest single impurityRP-HPLC — C-terminal free acid (+1 Da)0.11% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance89.28%w/wNOT TESTED
Target-compound contenttotal peptide content × purity89.12%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen5.85mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content5.214mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim104.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.94%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography5.57%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.21%NOT TESTED
Endotoxinkinetic chromogenic LAL0.19EU/mg≤ 5.0PASS
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 procedureFaint haze, clearing on standingclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.502.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient7.72min7.73 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.040.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²52,393≥ 20,000PASS
Resolution to nearest impurityvs [D-Trp]-epimer0.81no 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.

0335967181007613435 Ipamorelin7.72 min · 99.82 % 7.89 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 52,393, and skew follows the reported asymmetry factor of 1.04. 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 0.11 % impurity against a 99.82 % 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 peak7.724,851,56199.82
2C-terminal free acid (+1 Da)7.895,3460.11+0.984
3oxidised Trp (+16 Da)7.402,4300.05+15.995
4[D-Trp]-epimer7.619720.020.000
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 Fischer4.94
Counter-ion (acetate)ion chromatography5.57
Residual solvent + inorganic residueestimated0.21
Total peptide contentby difference89.28
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)99.7699.82divergence -0.07 pp vs batch median
Total impurities (% area)0.240.18
Largest single impurity (% area)0.180.11
Water (%)4.04.94
Counter-ion (%)7.55.57
Peptide content (%w/w)87.989.28
Endotoxin (EU/mg)not stated0.19
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, 4 d) → laboratory (hand-carried, 6 d) → assay.
Assay date
03 Sep 2025
Submitted to the index
04 Sep 2025
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 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.

buyer_sourced
A retail vial at 99.82 % is worth more evidentially than a selected vial at a higher figure. That is the whole argument for recording provenance at all.
ash_sulfated
Sulfated ash would split the inorganic remainder out of the residual slot. It is cheap, orthogonal, and would tighten this balance from good to complete.
nmr_qnmr
Quantitative NMR would give absolute content independent of the balance and let the two be cross-checked. On a record like this the balance is already closed; the cross-check would test the assumption behind it.
Section 7

Related records

Same batch — lot AMB-2505-J6078 n=13

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-019291AMB-2505-J6078Janoshik2025-Q399.505.06103.8Buyer-sourced0PASS
AX-2025-019292AMB-2505-J6078Janoshik2025-Q399.834.33Buyer-sourced0PASS
AX-2025-019293AMB-2505-J6078PeptideMeter2025-Q399.544.8598.2Buyer-sourced0PASS
AX-2025-019294AMB-2505-J6078Janoshik2025-Q399.934.53100.5Laboratory-retained0PASS
AX-2025-019295AMB-2505-J6078PeptideMeter2025-Q399.935.38Buyer-sourced0PASS
AX-2025-019297AMB-2505-J6078Janoshik2025-Q399.835.10Buyer-sourced0PASS
AX-2025-019298AMB-2505-J6078Janoshik2025-Q399.865.2792.7Buyer-sourced0PASS
AX-2025-019299AMB-2505-J6078Medutest2025-Q399.334.84Buyer-sourced0PASS
AX-2025-019300AMB-2505-J6078Janoshik2025-Q399.414.88103.8Buyer-sourced0PASS
AX-2025-019301AMB-2505-J6078Kestrel2025-Q399.934.6892.5Buyer-sourced0PASS
AX-2025-019302AMB-2505-J6078Janoshik2025-Q399.504.75Buyer-sourced0PASS
AX-2025-019303AMB-2505-J6078Janoshik2025-Q399.934.86Buyer-sourced0PASS
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 AMB records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042002SemaglutideAMB-2607-N6274VendorInvestigate2026-Q398.236.3797.1Buyer-sourced1MARGINAL
AX-2026-042012GHRP-6AMB-2603-S5667Janoshik2026-Q399.375.9088.8Laboratory-retained1MARGINAL
AX-2026-041974TirzepatideAMB-2603-C5112Nordanalyt2026-Q398.203.41Buyer-sourced0PASS
AX-2026-041975TirzepatideAMB-2603-C5112Medutest2026-Q397.883.45106.9Laboratory-retained0PASS
AX-2026-042005SemaglutideAMB-2607-N6274PeptideMeter2026-Q398.096.4898.6Buyer-sourced1MARGINAL
AX-2026-042008EpitalonAMB-2602-Y6433Janoshik2026-Q399.308.75105.1Buyer-sourced0PASS
AX-2026-042021TB-500AMB-2602-P5987VendorInvestigate2026-Q399.864.79101.4Buyer-sourced0PASS
AX-2026-042015GHRP-6AMB-2603-S5667Janoshik2026-Q399.546.4497.1Buyer-sourced0PASS