AssayIndex

AX-2025-018587

ARA-290 · 10 mg declared · ChinaPeptides Co., Ltd. (QYAOBIO) · lot QYB-2511-Y5015

MARGINALVERIFIED
Report ID
AX-2025-018587
Compound
ARA-290
Compound class
Tissue-repair and immunomodulatory peptides
Supplier
QYB — ChinaPeptides Co., Ltd. (QYAOBIO)
Batch / lot
QYB-2511-Y5015
Declared label claim
10mg
Laboratory
Nordanalyt Laboratories
Assay date
17 Dec 2025
Submitted
21 Dec 2025
Quarter
2025-Q4
Submitter
sa.ivaturi
Sample provenance
Supplier-supplied
Section 1

Results

Measured against the index acceptance specification for the tissue-repair and immunomodulatory 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 nm99.83% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.17% area≤ 2.0PASS
Largest single impurityRP-HPLC — deamidated (+1 Da)0.11% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula1189.6096DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)1189.6129DaNOT TESTED
Mass accuracyobserved vs theoretical+2.8ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance88.70%w/wNOT TESTED
Target-compound contenttotal peptide content × purity88.55%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen10.25mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content9.076mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim90.8%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate5.24%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography5.43%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.63%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 calibration4.842.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient10.09min10.06 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.240.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²57,923≥ 20,000PASS
Resolution to nearest impurityvs [D-Ser]-diastereomer0.81no 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.

02461492273839844 ARA-29010.09 min · 99.83 % 9.83 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 57,923, and skew follows the reported asymmetry factor of 1.24. 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 99.83 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1ARA-290 — main peak10.094,852,04799.83
2deamidated (+1 Da)9.835,3460.11+0.984
3[D-Ser]-diastereomer9.951,9440.040.000
4acetyl adduct (+42 Da)10.569720.02+42.011
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 1189.6096 Da, computed from C50H83N15O18. All ppm figures on this site are against monoisotopic values — see why that matters.

025507510027545062580097511501325 [M+1H]1+1190.62[M+2H]2+595.81 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 1189.6129 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 (%)
3+397.5438397.54490.00117.6
2+595.8121595.81370.001649.9
1+1190.61691190.62020.0033100.0
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 Fischer5.24
Counter-ion (acetate)ion chromatography5.43
Residual solvent + inorganic residueestimated0.63
Total peptide contentby difference88.70
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)99.9099.83divergence +0.07 pp vs batch median
Total impurities (% area)0.100.17
Largest single impurity (% area)0.070.11
Water (%)3.85.24
Counter-ion (%)7.75.43
Peptide content (%w/w)87.988.70
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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 9 d) → assay. Submitter did not handle the vial.
Assay date
17 Dec 2025
Submitted to the index
21 Dec 2025
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 min gradient · high-resolution MS
Verification status
VERIFIED
Section 6

Annotations

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot QYB-2511-Y5015 n=5

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-018584QYB-2511-Y5015Janoshik2025-Q499.935.61Supplier-supplied1MARGINAL
AX-2025-018585QYB-2511-Y5015VendorInvestigate2025-Q498.465.43Buyer-sourced1MARGINAL
AX-2025-018586QYB-2511-Y5015Nordanalyt2025-Q499.585.5594.7Supplier-supplied2MARGINAL
AX-2025-018588QYB-2511-Y5015Nordanalyt2025-Q499.935.39Supplier-supplied1MARGINAL
Other recent ARA-290 records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041852JEEPJEEP-2601-K3139Janoshik2026-Q299.034.60Buyer-sourced1MARGINAL
AX-2026-043211SGNSGN-2605-X9661PeptideMeter2026-Q297.967.11101.7Supplier-supplied1FAIL
AX-2026-041857JEEPJEEP-2601-K3139Kestrel2026-Q299.094.21Supplier-supplied1MARGINAL
AX-2026-043212SGNSGN-2605-X9661PeptideMeter2026-Q298.587.00Supplier-supplied1MARGINAL
AX-2026-041853JEEPJEEP-2601-K3139PeptideMeter2026-Q298.504.5194.7Laboratory-retained1MARGINAL
AX-2026-041856JEEPJEEP-2601-K3139Janoshik2026-Q299.634.2992.0Supplier-supplied1MARGINAL
AX-2026-041851JEEPJEEP-2601-K3139Janoshik2026-Q299.004.51Supplier-supplied1MARGINAL
AX-2026-041858JEEPJEEP-2601-K3139VendorInvestigate2026-Q298.824.14Buyer-sourced1MARGINAL
Other recent QYB records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041453RetatrutideQYB-2604-B5660VendorInvestigate2026-Q398.022.55Buyer-sourced1MARGINAL
AX-2026-041454RetatrutideQYB-2604-B5660Janoshik2026-Q398.842.77Supplier-supplied1MARGINAL
AX-2026-041538RetatrutideQYB-2602-G6308Medutest2026-Q398.502.85Supplier-supplied2MARGINAL
AX-2026-041456RetatrutideQYB-2604-B5660Janoshik2026-Q398.233.24Supplier-supplied1MARGINAL
AX-2026-041452RetatrutideQYB-2604-B5660Nordanalyt2026-Q398.503.36Supplier-supplied1MARGINAL
AX-2026-041427IpamorelinQYB-2605-H4298Janoshik2026-Q399.934.12Supplier-supplied0PASS
AX-2026-041488PT-141 (Bremelanotide)QYB-2607-L5615Janoshik2026-Q399.933.79Supplier-supplied0PASS
AX-2026-041459RetatrutideQYB-2604-B5660VendorInvestigate2026-Q397.912.8492.2Buyer-sourced1MARGINAL