AssayIndex

AX-2026-041892

Ipamorelin · 2 mg declared · SinoPep Biotechnology (Changzhou) Co., Ltd. · lot SNP-2602-B3833

MARGINALVERIFIED
Report ID
AX-2026-041892
Compound
Ipamorelin
Compound class
Growth-hormone axis peptides
Supplier
SinoPep — SinoPep Biotechnology (Changzhou) Co., Ltd.
Batch / lot
SNP-2602-B3833
Declared label claim
2mg
Laboratory
Nordanalyt Laboratories
Assay date
05 Jul 2026
Submitted
23 Jul 2026
Quarter
2026-Q3
Submitter
l.falk
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, 35 min gradient, 214 nm99.73% area≥ 99.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.27% area≤ 1.0PASS
Largest single impurityRP-HPLC — [D-Trp]-epimer0.19% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula711.3856DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)711.3836DaNOT TESTED
Mass accuracyobserved vs theoretical-2.8ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance88.74%w/wNOT TESTED
Target-compound contenttotal peptide content × purity88.50%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen2.01mg2 mg declaredNOT TESTED
Recovered target peptidegross fill × target content1.779mg2 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim88.9%90.0 – 110.0FAIL
Water contentKarl Fischer, coulometric, duplicate5.35%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography5.50%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.41%NOT TESTED
Endotoxinkinetic chromogenic LAL2.03EU/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 procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.242.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient9.56min9.50 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.090.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²52,180≥ 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.

026405279791910559 Ipamorelin9.56 min · 99.73 % 9.42 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0510152025303540 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 35 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 52,180, and skew follows the reported asymmetry factor of 1.09. 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 0.19 % impurity against a 99.73 % 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 peak9.564,847,18799.73
2[D-Trp]-epimer9.429,2350.190.000
3C-terminal free acid (+1 Da)9.772,4300.05+0.984
4des-Lys (−128 Da)9.309720.02-128.095
5oxidised Trp (+16 Da)9.164860.01+15.995
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+712.39[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 711.3836 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+356.7001356.6991-0.001052.2
1+712.3929712.3909-0.0020100.0
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.

ComponentDetermination%w/w of cake
WaterKarl Fischer5.35
Counter-ion (acetate)ion chromatography5.50
Residual solvent + inorganic residueestimated0.41
Total peptide contentby difference88.74
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)99.9099.73divergence -0.03 pp vs batch median
Total impurities (% area)0.100.27
Largest single impurity (% area)0.050.19
Water (%)not stated5.35
Counter-ion (%)not stated5.50
Peptide content (%w/w)not stated88.74
Endotoxin (EU/mg)not stated2.03
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 → third-party forwarder (1 d) → laboratory (courier, cold pack, 5 d) → assay.
Assay date
05 Jul 2026
Submitted to the index
23 Jul 2026
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 min gradient · high-resolution MS
Verification status
VERIFIED
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.

selection_bias
Provenance handles supplier selection. It does not handle submitter selection, which is the larger confounder and the one the index cannot measure.
price_per_mg
The index cannot verify that the vial assayed is representative of the lot it came from, and says so on every record. Provenance narrows that gap; it does not close it.
triptorelin_dtrp
Enantiomeric and epimeric impurities are the extreme case: identical mass, near-identical retention, and separable only by a method chosen for the purpose.
units_pedant
The comparison that matters is cost per milligram of recovered peptide, not cost per vial. On this lot the two differ by about a sixth.
Section 7

Related records

Same batch — lot SNP-2602-B3833 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041891SNP-2602-B3833Janoshik2026-Q399.935.11Buyer-sourced1MARGINAL
AX-2026-041893SNP-2602-B3833Janoshik2026-Q399.804.62100.4Buyer-sourced1MARGINAL
AX-2026-041894SNP-2602-B3833Janoshik2026-Q399.844.8197.4Laboratory-retained1MARGINAL
AX-2026-041895SNP-2602-B3833Janoshik2026-Q399.934.72105.9Buyer-sourced1MARGINAL
AX-2026-041896SNP-2602-B3833Janoshik2026-Q399.935.2196.9Supplier-supplied1MARGINAL
AX-2026-041897SNP-2602-B3833Janoshik2026-Q399.775.12Buyer-sourced1MARGINAL
AX-2026-041898SNP-2602-B3833Nordanalyt2026-Q399.934.5496.0Buyer-sourced1MARGINAL
AX-2026-041899SNP-2602-B3833PeptideMeter2026-Q399.934.9690.1Buyer-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 SinoPep records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041867CJC-1295 with DACSNP-2607-C3886Janoshik2026-Q399.245.12Laboratory-retained1FAIL
AX-2026-041913IpamorelinSNP-2606-L4478PeptideMeter2026-Q398.885.28Buyer-sourced0FAIL
AX-2026-041914IpamorelinSNP-2606-L4478Janoshik2026-Q399.145.49Buyer-sourced0PASS
AX-2026-041909IpamorelinSNP-2606-L4478PeptideMeter2026-Q399.005.4889.5Buyer-sourced1MARGINAL
AX-2026-041895IpamorelinSNP-2602-B3833Janoshik2026-Q399.934.72105.9Buyer-sourced1MARGINAL
AX-2026-041930IGF-1 LR3SNP-2606-D4620Medutest2026-Q398.545.3793.8Buyer-sourced0PASS
AX-2026-041898IpamorelinSNP-2602-B3833Nordanalyt2026-Q399.934.5496.0Buyer-sourced1MARGINAL
AX-2026-041931IGF-1 LR3SNP-2606-D4620PeptideMeter2026-Q397.935.1993.4Buyer-sourced0PASS